Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-26 @ 9:21 PM
Study NCT ID:
NCT05799092
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2023-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', '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 from any causes, myocardial infarction (MI), clinically driven unplanned revascularization.'}], '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': 'Any MI', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Defined by Forth Universal definition of MI'}, {'measure': 'Spontaneous MI', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Defined by Forth Universal definition of MI'}, {'measure': 'Procedure-related MI', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Defined by ARC II definition'}, {'measure': 'Resuscitated cardiac arrest', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Resuscitated cardiac arrest'}, {'measure': 'Unplanned revascularization (clinically driven)', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Unplanned revascularization (clinically driven)'}, {'measure': 'Cerebrovascular accidents', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Cerebrovascular accidents (ischemic or hemorrhagic)'}, {'measure': 'Major adverse cardiac and cerebrovascular events', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Major adverse cardiac and cerebrovascular events (MACCE, a composite of death, MI, clinically-driven unplanned revascularization, or cerebrovascular accident)'}, {'measure': 'Rate of index coronary angiography', 'timeFrame': 'up to 30 days following randomization', 'description': 'Rate of index coronary angiography'}, {'measure': 'Rate of index revascularization by PCI or CABG', 'timeFrame': 'up to 30 days following randomization', 'description': 'Rate of index revascularization by PCI or CABG'}, {'measure': 'European Quality of Life-5 Dimensions', 'timeFrame': '6 months after initial management according to allocated diagnostic test', 'description': 'European Quality of Life-5 Dimensions'}, {'measure': 'Seattle Angina Questionnaire', 'timeFrame': '6 months after initial management according to allocated diagnostic test', 'description': 'Seattle Angina Questionnaire'}, {'measure': 'Total medical cost', 'timeFrame': '2 years after the last patient enrollment', 'description': 'Total medical cost'}, {'measure': 'Procedure-related complications from invasive procedure', 'timeFrame': 'up to 30 days following randomization', 'description': 'Procedure-related complications from invasive procedure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Computed Tomography Angiography', 'Non-High Risk Obstructive CAD', 'Diagnostic Approach', 'Invasive Coronary Angiography', 'Non-Invasive Functional Test'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'A pragmatic, prospective, multi-center, open label, randomized controlled, superiority trial.\n\nThe study will compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive coronary artery disease (CAD) on coronary computed tomography-angiography (CCTA).', 'detailedDescription': "CCTA has been emerged as useful diagnostic tool to evaluate CAD. Besides high diagnostic accuracy, CCTA has additional benefit of measuring the cumulative atherosclerotic burden and more accurately discriminating obstructive CAD with additional fractional flow reserve by CT (FFRCT), making it more predictive of a patient's prognosis. Recently, several randomized clinical trials have demonstrated the clinical utility of CCTA when compared with noninvasive stress test, which has been previously widely used as an initial assessment for stable chest pain, or invasive coronary angiography, which is the gold standard for diagnosing obstructive CAD.\n\nOn this background, CCTA, along with stress imaging test, is recommended as first step to diagnose obstructive CAD in patients with intermediate to high pretest probabilities with stable chest pain and is increasingly utilized. Although CCTA is increasingly used as initial assessment tool in these patients, there are insufficient studies to clearly establish the next step after obstructive CAD is confirmed in CCTA. Without high-risk features of CAD on CCTA, current guidelines suggest noninvasive stress imaging or FFRCT as class IIA recommendation. However, supporting evidence of these suggestions are mostly based on studies with low level of evidence. Furthermore, given the limited diagnostic performance of noninvasive stress test, concern remains whether it is safe to defer invasive coronary angiography based on the result from noninvasive stress test in patients with obstructive CAD on CCTA.\n\nTherefore, this trial aims to compare clinical outcomes between invasive versus non-invasive approach as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject age ≥19 years old\n2. Patients with new or worsening chest pain syndrome, equivalent symptoms, or abnormal laboratory test findings (suspected ischemic changes in electrocardiography, regional wall motion abnormality in echocardiography, or coronary calcium score \\> 100) suspected for clinically significant CAD who are evaluated by CCTA\n3. Any other clinical circumstance in which physician judged to proceed CCTA\n4. Obstructive CAD in CCTA (≥50% diameter stenosis)\n5. Subject who can verbally confirm understandings of risks, benefits, and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.\n\nExclusion Criteria:\n\n1. Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing (elevated cardiac troponin or CK-MB)\n2. High risk CAD (left main stenosis ≥ 50%; anatomically significant 3-vessel disease with ≥70% stenosis)\n3. Hemodynamically or clinically unstable condition (systolic BP \\< 90 mmHg, ventricular arrhythmias, or persistent resting chest pain in ischemic nature despite adequate therapy\n4. Known CAD with previous MI, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)\n5. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)\n6. Known significant congenital, severe valvular or cardiomyopathic (hypertrophic or dilated cardiomyopathy, or any other forms) process which could explain cardiac symptoms.\n7. Severe left ventricular systolic dysfunction (ejection fraction \\<30%)\n8. Intolerance to Aspirin, Clopidogrel, or Heparin.\n9. Non-cardiac co-morbid conditions are present with life expectancy \\<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n10. Unwillingness or inability to comply with the procedures described in this protocol."}, 'identificationModule': {'nctId': 'NCT05799092', 'acronym': 'SMART-STEP', 'briefTitle': 'Invasive Versus Non-invasive Approach in Symptomatic Patient With Non-High Risk Coronary Artery Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Invasive Versus Non-invasive Approach in Symptomatic Patients With Non-High Risk Coronary Artery Stenosis (SMART-STEP Trial)', 'orgStudyIdInfo': {'id': 'SMC2023-02-096-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Invasive approach group', 'description': 'Invasive coronary angiography will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA..', 'interventionNames': ['Diagnostic Test: Invasive coronary angiography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-invasive approach group', 'description': 'Usual care of non-invasive ischemia testing (exercise electrocardiography \\[ECG\\], stress echocardiography by exercise or pharmacologic agent, nuclear test including SPECT or PET, stress cardiac magnetic resonance \\[MR\\]) will be performed as next diagnostic step in symptomatic patients with non-high risk obstructive CAD on CCTA.', 'interventionNames': ['Diagnostic Test: Non-invasive functional test']}], 'interventions': [{'name': 'Invasive coronary angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'As alternative to non-invasive functional testing, invasive coronary angiography will be performed.', 'armGroupLabels': ['Invasive approach group']}, {'name': 'Non-invasive functional test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard non-invasive functional testing will be performed.', 'armGroupLabels': ['Non-invasive approach group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'status': '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': 'Chuncheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byung Ryul Cho, MD, PhD', 'role': 'CONTACT', 'email': 'heartcho@kangwon.ac.kr'}, {'name': 'Byung Ryul Cho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Chungju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woong Gil Choi, MD, PhD', 'role': 'CONTACT', 'email': 'wooggil7@gmail.com'}, {'name': 'Woong Gil Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.97666, 'lon': 127.9287}}, {'city': 'Daegu', 'status': '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': 'Jang Hoon Lee, MD, PhD', 'role': 'CONTACT', 'email': 'ljhmh75@knu.ac.kr'}, {'name': 'Namkyun Kim, MD, PhD', 'role': 'CONTACT', 'email': 'namkyun.kim@knu.ac.kr'}, {'name': 'Jang Hoon Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Namkyun Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin-Ok Jeong, MD, PhD', 'role': 'CONTACT', 'email': 'jojeong@cnu.ac.kr'}, {'name': 'Pil Sang Song, MD, PhD', 'role': 'CONTACT', 'email': 'pssong73@gmail.com'}, {'name': 'Pil Sang Song, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jin-Ok Jeong, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gwangju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Joon Hong, MD, PhD', 'role': 'CONTACT', 'email': 'hyj200@hanmail.net'}, {'name': 'Seung Hun Lee, MD, PhD', 'role': 'CONTACT', 'email': 'lsh8602@naver.com'}, {'name': 'Young Joon Hong, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Seung Hun Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chonnam National University', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gwangmyeong', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Yeub Lee, MD, PhD', 'role': 'CONTACT', 'email': 'louisahj@gmail.com'}, {'name': 'Sang Yeub Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chung-Ang University Gwangmyeong Hospital', 'geoPoint': {'lat': 37.47722, 'lon': 126.86639}}, {'city': 'Ilsan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joonhyung Doh, MD, PhD', 'role': 'CONTACT', 'email': 'joon.doh@gmail.com'}, {'name': 'Sung Eun Kim, MD, PhD', 'role': 'CONTACT', 'email': 'I0540@paik.ac.kr'}, {'name': 'Joonhyung Doh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sung Eun Kim, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Inje university Ilsan Paik hospital', 'geoPoint': {'lat': 35.5, 'lon': 129.43333}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung Hwan Han, MD, PhD', 'role': 'CONTACT', 'email': 'kheartist@gmail.com'}, {'name': 'Seung Hwan Han, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Incheon', 'status': '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': 'Jinju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Sin Koh, MD, PhD', 'role': 'CONTACT', 'email': 'kjs0175@gmail.com'}, {'name': 'Hangyul Kim, MD, PhD', 'role': 'CONTACT', 'email': '13medicine@naver.com'}, {'name': 'Hangyul Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jin Sin Koh, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'city': 'Seongnam-si', 'status': '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}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ho Youn Won, MD, PhD', 'role': 'CONTACT', 'email': 'nowhy@cau.ac.kr'}, {'name': 'Ho Youn Won, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyung-Jin Kim, MD, PhD', 'role': 'CONTACT', 'email': 'kyungjinkimkorea@gmail.com'}, {'name': 'So-Dam Jung, MD, PhD', 'role': 'CONTACT', 'email': 'cvdosam@gmail.com'}, {'name': 'Kyung-Jin Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'So-Dam Jung, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ewha Womans University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': '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': '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': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong-Young Lee, MD, PhD', 'role': 'CONTACT', 'email': 'jyleeheart@naver.com'}, {'name': 'Woochan Kwon, MD, PhD', 'role': 'CONTACT', 'email': 'danced1@naver.com'}, {'name': 'Jong-Young Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Woochan Kwon, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seung-Jae Lee, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': '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': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joo Myung Lee, MD, MPH, PhD', 'role': 'CONTACT', 'email': 'drone80@hanmail.net', 'phone': '82-2-3410-2575'}, {'name': 'David Hong, MD', 'role': 'CONTACT', 'email': 'hongdawi@naver.com', 'phone': '82-2-3410-2575'}, {'name': 'Joo Myung Lee, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Hong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': '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': '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}}], 'centralContacts': [{'name': 'Joo Myung Lee, MD, MPH, PhD', 'role': 'CONTACT', 'email': 'drone80@hanmail.net', 'phone': '82-2-3410-3391'}, {'name': 'David Hong, MD', 'role': 'CONTACT', 'email': 'hongdawi@naver.com', 'phone': '82-2-3410-3391'}], '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': 'Professor', 'investigatorFullName': 'Joo Myung Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}