Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-10 @ 9:23 PM
Study NCT ID:
NCT03700567
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2018-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2018-09-29', 'studyFirstSubmitQcDate': '2018-10-07', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate of PCI-related myocardial injury in UAP patients 3 days after PCI', 'timeFrame': '3 days after PCI', 'description': 'the incidence rate of PCI-related myocardial injury indicated by the changes of myocardial injury biomarkers (such as TNI and CK-MB) in UAP patients between low temperature contrast and room temperature contrast groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low temperature', 'contrast', 'PCI-related myocardial injury'], 'conditions': ['Unstable Angina Pectoris']}, 'referencesModule': {'references': [{'pmid': '20562067', 'type': 'BACKGROUND', 'citation': 'Moschovitis A, Cook S, Meier B. Percutaneous coronary interventions in Europe in 2006. EuroIntervention. 2010 Jun;6(2):189-94. doi: 10.4244/EIJV7I6A31.'}, {'pmid': '19286891', 'type': 'BACKGROUND', 'citation': 'Testa L, Van Gaal WJ, Biondi Zoccai GG, Agostoni P, Latini RA, Bedogni F, Porto I, Banning AP. Myocardial infarction after percutaneous coronary intervention: a meta-analysis of troponin elevation applying the new universal definition. QJM. 2009 Jun;102(6):369-78. doi: 10.1093/qjmed/hcp005. Epub 2009 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous coronary intervention (PCI) has become one of the main treatments for rapid recovery of revascularization in patients with coronary heart disease (CHD). PCI has some advantages, such as easy operation, small trauma and rapid recovery. It can significantly improve myocardial ischemic symptom and reduce the incidence of cardiovascular adverse events in CHD patients. However, many studies have found that the incidence of PCI-related myocardial injury is relatively high, and affect the efficacy of PCI and prognosis in patients with unstable angina pectoris (UAP). A meta-analysis of a total of 7578 patients with UAP from 15 studies who underwent PCI was found to have a 28.7% increase in myocardial biomarkers after PCI. The objective of this randomized control trial is to gain a clinical insight on the use of low temperature contrast for the treatment of PCI-related myocardial injury in UAP patients. The primary objective is assess efficacy and safety of low temperature contrast for the treatment of PCI-related myocardial injury in UAP patients.', 'detailedDescription': 'The current study is designed as a multicenter, randomized and prospective study aiming to compare the change in levels of myocardial injury biomarkers (such as TNI and CK-MB) between low temperature contrast group and room temperature contrast group. Based on previous study, the incidence rate of PCI-related myocardial injury is 28.7% in UAP patients undergoing PCI. And in our study the expected incidence rate of PCI-related myocardial injury is up to 14.3% in UAP patients undergoing PCI after treatment with low temperature contrast. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 440 UAP patients were required, and with 220 patients per group as a ratio of 1:1 randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* De novo lesions\n* Those who meet the diagnostic criteria of unstable angina pectoris\n* New generation drug eluting stent implantation\n* Only single coronary artery treated at this time\n\nExclusion Criteria:\n\n* Those who meet the diagnostic criteria of acute myocardial infarction\n* Those who meet the diagnostic criteria of stable angina pectoris\n* Patients with cardio-genic shock\n* Patients with multiple organ failure\n* Patients allergic to contrast\n* Patients who can not tolerate dual antiplatelet therapy\n* Patients who can't tolerate anticoagulation\n* Recently infected patients\n* Patients with hepatorenal dysfunction\n* Thrombotic lesion of coronary artery\n* Chronic total coronary occlusion lesion\n* Patients with complex coronary bifurcation requiring two stent strategy\n* Severe coronary calcified lesion\n* Patients with percutaneous coronary angioplasty\n* Patients with directional coronary atherectomy or rotational atherectomy\n* Patients with drug coated balloon treatment\n* Patients with bioabsorbable vascular scaffold implantation\n* Previous percutaneous coronary intervention or coronary artery bypass graft\n* Patients with active stage of autoimmune disease"}, 'identificationModule': {'nctId': 'NCT03700567', 'acronym': 'LOTA-I', 'briefTitle': 'Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Safety and Efficacy of Low Temperature Contrast for the Treatment of PCI-related Myocardial Injury in Patients With Unstable Angina Pectoris (LOTA-I)', 'orgStudyIdInfo': {'id': 'KY20180713-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low temperature contrast', 'description': 'A total of 220 patients are assigned to low temperature contrast group after randomization schedule.', 'interventionNames': ['Other: low temperature contrast']}, {'type': 'NO_INTERVENTION', 'label': 'room temperature contrast', 'description': 'A total of 220 patients are assigned to room temperature contrast group after randomization schedule.'}], 'interventions': [{'name': 'low temperature contrast', 'type': 'OTHER', 'description': 'UAP patients undergoing PCI were performed with low temperature contrast. The investigators used thermal insulation equipment to keep contrast at 5℃. The EKG and blood pressure were monitored during the PCI procedure. After PCI, the investigators monitored levels of myocardial injury biomarkers for 3 days every 8 hours.', 'armGroupLabels': ['low temperature contrast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '239000', 'city': 'Chuzhou', 'state': 'Anhui', 'country': 'China', 'facility': "The First People's Hospital of Chuzhou", 'geoPoint': {'lat': 32.32194, 'lon': 118.29778}}, {'zip': '239400', 'city': 'Chuzhou', 'state': 'Anhui', 'country': 'China', 'facility': "MingGuang People's Hospital", 'geoPoint': {'lat': 32.32194, 'lon': 118.29778}}, {'zip': '213000', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "The First People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '222061', 'city': 'Lianyungang', 'state': 'Jiangsu', 'country': 'China', 'facility': "The First People's Hospital of Lianyungang", 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '221006', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '214200', 'city': 'Yixing', 'state': 'Jiangsu', 'country': 'China', 'facility': "The People's hospital of Yixing", 'geoPoint': {'lat': 31.36059, 'lon': 119.82016}}], 'overallOfficials': [{'name': 'Fei Ye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing First Hospital, Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}