Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT07009418
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant and care provider cannot be blinded. But, investigator and clinical outcoem assessor will be blinded about the randomly allocated groups. Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-14', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first event of major adverse cardiac events (MACE)', 'timeFrame': '2 years after the last patient enrollment', 'description': 'MACE is a composite of death, non-fatal myocardial infarction (MI), hospitalization for acute coronary syndrome leading to an urgent revascularization, or stent thrombosis'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': '2 years after the last patient enrollment', 'description': 'All-cause death'}, {'measure': 'Cardiac death', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Cardiac death'}, {'measure': 'Non-fatal MI', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Non-fatal MI, defined by Forth Universal definition of MI'}, {'measure': 'Spontaneous MI', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Spontaneous MI, defined by Forth Universal definition of MI'}, {'measure': 'Procedure-related MI (during follow-up period from invasive procedure)', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Procedure-related MI (during follow-up period from invasive procedure), defined by Fourth Universal definition of MI'}, {'measure': 'Hospitalization for acute coronary syndrome leading to an urgent revascularization', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Hospitalization for acute coronary syndrome is defined as a clinical event in which the final diagnosis during unplanned hospitalization is acute coronary syndrome including spontaneous myocardial infarction or unstable angina.'}, {'measure': 'Unplanned revascularization (clinically-driven)', 'timeFrame': '2 years after the last patient enrollment', 'description': 'All revascularization events will be adjudicated as either clinically-driven or non-clinically-driven. Revascularization will be considered clinically-driven if the diameter stenosis of the revascularized coronary segment is ≥50% by QCA and any of the following criteria for ischemia are met:\n\n* A positive functional study corresponding to the area served by the target lesion; or\n\n * Ischemic ECG changes at rest in a distribution consistent with the target vessel; or\n\n * Typical ischemic symptoms referable to the target lesion; or ④ positive invasive physiologic test (fractional flow reserve ≤0.80 or instantaneous wave-free ratio ≤0.89); or ⑤ presence of stenosis with ≥70% diameter stenosis, even in the absence of other criteria Unplanned revascularization refers to revascularization not planned after initial assessments with invasive coronary angiography or non-invasive stress testing, depending on the allocated group, but performed due to clinical circumstances.'}, {'measure': 'Definite stent thrombosis', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Definite stent thrombosis, defined by Academic Research Consortium (ARC) II consensus'}, {'measure': 'Rate of invasive coronary angiography during follow-up', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Rate of invasive coronary angiography (with or without showing restenosis or obstructive CAD) during follow-up.\n\nAngiographic restenosis was defined as a stenosis of at least 50 percent of the minimal luminal diameter in the target-lesion at invasive coronary angiography during follow-up. Obstructive or no obstructive coronary artery disease at invasive coronary angiography is defined as a visually estimated presence or absence of stenosis of 50% or more, as interpreted by the study-site staff, in any major epicardial vessel, including side branches of at least 2.5 mm in diameter.'}, {'measure': 'Rate of revascularization by PCI or CABG during follow-up', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Rate of revascularization by PCI or CABG during follow-up'}, {'measure': 'Procedure-related complications from invasive procedure during follow-up', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Procedure-related complications from invasive procedure during follow-up'}, {'measure': 'Cerebrovascular accidents', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Cerebrovascular accidents (ischemic or hemorrhagic)'}, {'measure': 'Contrast-induced nephropathy or contrast-associated hypersensitivity reaction', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Contrast-induced nephropathy, defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure or contrast-associated hypersensitivity reaction'}, {'measure': 'Total medical cost', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Total medical cost'}, {'measure': 'A composite of death or non-fatal MI', 'timeFrame': '2 years after the last patient enrollment', 'description': 'A composite of death or non-fatal MI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'percutaneous coronary intervention', 'coronary computed tomography angiography', 'follow-up strategy'], 'conditions': ['Ischemic Heart Disease', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the SMART-CARE trial is to compare clinical outcomes between coronary CT angiography (CCTA) versus standard care as follow-up strategies in high-risk patients after percutaneous coronary intervention (PCI).', 'detailedDescription': 'Advancements in drug-eluting stents, physiology-guided treatment decisions, intravascular imaging-guided procedural optimization, and adjunctive medical therapy have significantly improved prognosis after percutaneous coronary intervention (PCI). However, high-risk patients-particularly those with complex coronary artery lesions or high-risk clinical conditions such as acute myocardial infarction with or without cardiogenic shock at presentation, diabetes mellitus which requires medical treatment (oral hypoglycemic agents or insulin), end-stage renal disease under dialysis, or multi-vascular disease-continue to have a significantly higher risk of adverse cardiovascular events. In this regard, meticulous follow-up, including periodic assessment of clinical and functional status, guideline-directed medical therapy (GDMT), and secondary prevention strategies are important, and current guidelines strongly recommend these measures as a Class I recommendation. However, recent randomized controlled trials have demonstrated that high-risk patients with complex coronary artery disease or high-risk clinical conditions still experience a continuous increase in adverse cardiovascular events despite optimal secondary prevention. This underscores the need for an optimized surveillance strategy to improve long-term prognosis.\n\nDespite the emphasis on GDMT and secondary prevention in current guidelines, the most effective surveillance strategy after PCI remains uncertain. Existing recommendations primarily address secondary prevention and provide only limited guidance on surveillance for patients with previous coronary revascularization. Based on multiple randomized controlled trials, current guidelines do not recommend routine non-invasive stress testing or coronary CT angiography (CCTA) in asymptomatic patients receiving optimized GDMT (Class III, Level of Evidence B-R). However, this recommendation lacks direct evidence evaluating CCTA as a surveillance strategy after PCI. In patients with prior coronary revascularization, CCTA is currently recommended for assessing bypass graft or stent patency only in symptomatic patients (Class IIa), with limited supporting evidence (Level of Evidence B in ESC guidelines and Level of Evidence B-NR in ACC/AHA guidelines).\n\nNotably, the SCOT-HEART trial demonstrated that a CCTA-based treatment strategy was superior to standard care, which relied on clinical and functional assessment along with as-needed non-invasive stress testing, in reducing a composite outcome of coronary heart disease death and non-fatal myocardial infarction. This suggests that a surveillance strategy incorporating CCTA may lead to improved subsequent management decisions, such as preemptive ischemia-driven revascularization or intensified medical therapy, potentially reducing ischemic cardiovascular events and mortality compared to standard guideline-recommended care.\n\nTo address this critical gap in clinical practice, we designed the Smart Angioplasty Research Team-Coronary CT Angiography versus Standard Care as Follow-up Strategies in High-Risk Patients after PCI (SMART-CARE) trial. This study aims to evaluate the impact of a CCTA-based surveillance strategy on clinical outcomes compared with standard guideline-directed follow-up in high-risk patients who have undergone PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n① Patients aged 19 years old\n\n② Patients who underwent successful PCI with one or more contemporary drug-eluting stents (stent diameter ≥3mm) or drug-coated balloons.\n\n③ Patients must have at least one of the following criteria of complex coronary artery lesions or high-risk clinical characteristics:\n\nA. Complex coronary artery lesions:\n\ni. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size ii. Chronic total occlusion (≥3 months) as target lesion iii. PCI for unprotected left main (LM) disease (LM ostium, body, distal LM bifurcation including non-true bifurcation) iv. Long coronary lesions (used stents or drug-coated balloons ≥38 mm in length) v. Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session) vi. Multiple devices needed (≥3 more stents or drug-coated balloons per patient) vii. In-stent restenosis lesion as target lesion viii. Severely calcified lesion (encircling calcium in angiography) ix. Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion\n\nB. High-risk clinical characteristics:\n\ni. Acute myocardial infarction (ST-elevation myocardial infarction \\[MI\\] or non-ST-elevation MI) with or without cardiogenic shock (SCAI Classification ≥C) at presentation ii. Diabetes mellitus which requires medical treatment (oral hypoglycemic agents or insulin) iii. End-stage renal disease under dialysis iv. Combined vascular disease other than coronary artery disease\n\n1. Peripheral artery occlusive disease which is defined as A. Previous aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, or infra-inguinal arteries, or B. Previous limb or foot amputation for arterial vascular disease, or C. History of intermittent claudication and one or more of the following: 1) An ankle/arm blood pressure (BP) ratio \\< 0.90, or 2) Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound, or D. Previous carotid revascularization or asymptomatic carotid artery stenosis ≥50% as diagnosed by duplex ultrasound or angiography.\n2. Thoracoabdominal aortic disease which is defined as A. Documented thoracoabdominal aortic aneurysm by duplex ultrasound, angiography, or computed tomography angiography B. Previous endovascular or surgical treatment for thoracoabdominal aortic aneurysm\n\n ④ Subject who can verbally confirm understandings of risks, benefits and surveillance strategy alternatives of receiving CCTA and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.\n\n Exclusion Criteria:\n\n ① Advanced chronic kidney disease (Creatinine clearance \\<30 ml/min/1.73 m2) not on dialysis\n * Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)\n\n * Pregnancy or breast feeding ④ Non-cardiac co-morbid conditions are present with life expectancy \\<1 year or that may result in protocol non-compliance (per site investigator's medical judgment) ⑤ Unwillingness or inability to comply with the procedures described in this protocol."}, 'identificationModule': {'nctId': 'NCT07009418', 'acronym': 'SMART-CARE', 'briefTitle': 'Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Coronary Computed Tomography Angiography Versus Standard Care in High-Risk Patients After Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'SMC19801001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surveillance by CCTA Strategy Group', 'description': 'In the surveillance by CCTA group, patients will be evaluated by CCTA at 1 year from index hospitalization. CCTA will be done according to current acquisition guidelines.', 'interventionNames': ['Diagnostic Test: Coronary CT Angiography (CCTA)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care Strategy Group', 'description': "In the standard care group, patients will be managed according to the current guidelines. Regardless of symptoms, periodic visits will be performed by the charged physician. Secondary prevention including cardiovascular risk factor control, assessment of disease status, and comorbidities, and GDMT will be meticulously performed. In patients without a change in clinical or functional status, further evaluation by CCTA or non-invasive functional tests will not be performed. In this group, CCTA or non-invasive functional tests will be performed only for patients with significant change in clinical or functional status or with symptoms refractory to medical treatment.6,8 Whether patients will be referred for invasive coronary angiography will be determined by the charged physician according to patient's clinical or functional status and the results from CCTA or non-invasive functional tests according to current guidelines."}], 'interventions': [{'name': 'Coronary CT Angiography (CCTA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'In the surveillance by CCTA group, patients will be evaluated by CCTA at 1 year from index hospitalization. CCTA will be done according to current acquisition guidelines. Downstream management according to the results from CCTA will be performed under recommendations from current guidelines.', 'armGroupLabels': ['Surveillance by CCTA Strategy Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jon Suh, MD, PhD', 'role': 'CONTACT', 'email': 'marunada@gmail.com'}, {'name': 'Jon Suh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SoonChunHyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Daegu', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyuck Jun Yoon, MD, PhD', 'role': 'CONTACT', 'email': 'hippsons@gmail.com'}, {'name': 'Hyuck Jun Yoon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Namkyun Kim, MD, PhD', 'role': 'CONTACT', 'email': 'namkyun.kim@knu.ac.kr'}, {'name': 'Namkyun Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jang Hoon Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gwangju', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Hun Lee, MD, PhD', 'role': 'CONTACT', 'email': 'lsh8602@naver.com'}, {'name': 'Young Joon Hong, MD, PhD', 'role': 'CONTACT', 'email': 'hyj200@hanmail.net'}, {'name': 'Seung Hun Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Young Joon Hong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jun Ho Ahn, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chonnam National University Hospital, Chonnam National University Medical School', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gwangmyeong', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jinhwan Jo, MD, PhD', 'role': 'CONTACT', 'email': 'jjh8732@gmail.com'}, {'name': 'Jinhwan Jo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sang Yeub Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jun Hwan Cho, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chung-Ang University Gwangmyeong Hospital', 'geoPoint': {'lat': 37.47722, 'lon': 126.86639}}, {'city': 'Ilsan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Woo Cho, MD, PhD', 'role': 'CONTACT', 'email': 'drswcho@hanmail.net'}, {'name': 'Sung Woo Cho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sung-Eun Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hyun Cho, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Inje University College of Medicine, Ilsan Paik Hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Incheon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Albert Youngwoo Jang, MD, PhD', 'role': 'CONTACT', 'email': 'albert.jang.md@gmail.com'}, {'name': 'Albert Youngwoo Jang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyung-Bok Park, MD, PhD', 'role': 'CONTACT', 'email': 'hyungbok7@gmail.com'}, {'name': 'Hyung-Bok Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Kwandong University Intl. ST. Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeonju', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yisik Kim, MD, PhD', 'role': 'CONTACT', 'email': 'dr.kimesik@gmail.com'}, {'name': 'Yisik Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chang Hoon Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jeonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Jinju', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Sin Koh, MD, PhD', 'role': 'CONTACT', 'email': 'kjs0175@gmail.com'}, {'name': 'Jin Sin Koh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hangyul Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Min Gyu Kang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Seongnam-si', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ki-Hyun Jeon, MD, PhD', 'role': 'CONTACT', 'email': 'imcardio@gmail.com'}, {'name': 'Ki-Hyun Jeon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joo Myung Lee, MD, MPH, PhD', 'role': 'CONTACT', 'email': 'drone80@hanmail.net', 'phone': '0234102575'}, {'name': 'Joo Myung Lee, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ki-Hong Choi, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Taek Kyu Park, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeong Hoon Yang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Young Bin Song, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung-Taek Park, MD, PhD', 'role': 'CONTACT', 'email': 'whgdkdy05@gmail.com'}, {'name': 'Kyung-Taek Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ho Youn Won, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chung-Ang University Hospital, Chung-Ang University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Hoon Shin, MD, PhD', 'role': 'CONTACT', 'email': 'shin_sh@i.ewha.ac.kr'}, {'name': 'Sang Hoon Shin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ewha Womans University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Hyo Lim, MD, PhD', 'role': 'CONTACT', 'email': 'mdoim@hanyang.ac.kr'}, {'name': 'Young-Hyo Lim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hanyang University Seoul Hospital, College of Medicine, Hanyang University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Soon-Jun Hong, MD, PhD', 'role': 'CONTACT', 'email': 'psyche94@hanmail.net'}, {'name': 'Soon-Jun Hong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dong-Oh Kang, MD, PhD', 'role': 'CONTACT', 'email': 'gelly9@naver.com'}, {'name': 'Dong-Oh Kang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Kuro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-Shin Woo, MD, PhD', 'role': 'CONTACT', 'email': 'snowball77@hanmail.net'}, {'name': 'Jong-Shin Woo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Weon Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kyung Hee University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Sung Joh, MD, PhD', 'role': 'CONTACT', 'email': 'wingx4@naver.com'}, {'name': 'Hyun Sung Joh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Suwon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hong-Seok Lim, MD,PhD', 'role': 'CONTACT', 'email': 'hslimmd@hanmail.net'}, {'name': 'Hong-Seok Lim, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Uijeongbu-si', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Chan Joon Kim, MD, PhD', 'role': 'CONTACT', 'email': 'godandsci@naver.com'}, {'name': 'Chan Joon Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Seonghyeon Bu, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Catholic University of Korea Uijeongbu St. Mary's Hospital", 'geoPoint': {'lat': 37.7415, 'lon': 127.0474}}, {'city': 'Wŏnju', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung-Hee Lee, MD, PhD', 'role': 'CONTACT', 'email': 'seranflute@gmail.com'}, {'name': 'Jung-Hee Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'centralContacts': [{'name': 'Joo Myung Lee, MD, MPH, PhD', 'role': 'CONTACT', 'email': 'drone80@hanmail.net', 'phone': '+82234102575'}, {'name': 'Ki-Hong Choi, MD, PhD', 'role': 'CONTACT', 'email': 'cardiokh@gmail.com', 'phone': '+82234102575'}], 'overallOfficials': [{'name': 'Joo Myung Lee, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.', 'ipdSharing': 'YES', 'description': 'After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.', 'accessCriteria': 'After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Joo Myung Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}