Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 10:42 PM
Study NCT ID:
NCT06843005
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2025-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular and cerebrovascular event', 'timeFrame': '36 months after baseline', 'description': 'Record the number of participants experiencing major adverse cardiovascular and cerebrovascular event such as all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke'}], 'secondaryOutcomes': [{'measure': 'LDL-C control rate', 'timeFrame': '12 months after baseline', 'description': 'The proportion of participants with controlled LDL-C（\\<1.4mmol/L）'}, {'measure': 'Mean LDL-C changes', 'timeFrame': '12 months after baseline', 'description': 'Mean LDL-C changes of participants'}, {'measure': 'Adherence to lipid-lowering medication rate', 'timeFrame': '12 months after baseline', 'description': 'The proportion of participants who adhere to lipid-lowering drugs'}, {'measure': 'The difference in healthcare-seeking rates between the two groups', 'timeFrame': '12 months after baseline', 'description': 'The difference in healthcare-seeking rates between the two groups of patients, including both regular follow-ups and visits driven by clinical symptoms of coronary heart disease'}, {'measure': 'Hypertension control rate', 'timeFrame': '12 months after baseline', 'description': 'The proportion of participants with SBP\\<140mmHg and DBP\\<90mmHg.'}, {'measure': 'Diabetic control rate', 'timeFrame': '12 months after baseline', 'description': 'The proportion of participants with HbA1c \\<53 mmol/mol (7.0%).'}, {'measure': 'Cardiac death', 'timeFrame': '36 months after baseline', 'description': 'Number of participants diagnosed with cardiovascular death'}, {'measure': 'Fatal and non-fatal myocardial infarction or stroke', 'timeFrame': '36 months after baseline', 'description': 'Number of participants diagnosed with myocardial infarction or stroke'}, {'measure': 'Rehospitalization due to progressive angina', 'timeFrame': '36 months after baseline', 'description': 'Number of patients seeking medical care for unstable angina'}, {'measure': 'Major adverse cardiovascular event', 'timeFrame': '36 months after baseline', 'description': 'Record the number of participants experiencing major adverse cardiovascular events such as all-cause mortality, non-fatal myocardial infarction and ischemia driven revascularation'}, {'measure': 'Procedures', 'timeFrame': '36 months after baseline', 'description': 'The proportion of participants undergone procedures，including Invasive coronary angiography, percutaneous coronary intervention and coronary artery bypass graft surgery'}, {'measure': 'Radiation dose and incidental findings from CTCA', 'timeFrame': '36 months after baseline', 'description': 'The total radiation dose received by the participants during multiple examinations after enrollment.'}, {'measure': 'Change in quality of life (SF-12)', 'timeFrame': '36 months after baseline', 'description': 'Change in quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument'}, {'measure': 'The primary outcome in different subgroups', 'timeFrame': '36 months after baseline', 'description': 'The primary outcome (all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke) will be analyzed in prespecified subgroups, including age, sex, hypertension, diabetes mellitus, degree of stenosis on baseline CCTA.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Adverse Cardiovascular Events (MACE)', 'Prevention', 'Coronary Artery Disease(CAD)', 'CT Angiography']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.', 'detailedDescription': 'Patients with non-obstructive coronary artery disease have a high rate of adverse cardiovascular events, and currently, there is still a lack of effective management strategies for these patients in clinical practice. In the SUCCESS study, investigator will compare follow-up CCTA management with routine clinical management to assess the effectiveness of follow-up CCTA in improving lipid control and reducing cardiovascular events in these patients.\n\nThe SUCCESS study is a single-center, randomized, parallel-controlled, interventional clinical trial that recruits patients with non-obstructive coronary artery disease identified on previous CCTA (coronary artery stenosis of 20% to 70% or left main coronary artery stenosis of 20% to 50%). The experimental group is the CCTA follow-up management group, and the control group is the routine clinical follow-up management group. All participants will be randomly assigned to the experimental and control groups in a 1:1 ratio. The experimental group will undergo management using follow-up CCTA, while the control group will be managed using routine clinical and laboratory examinations. At the 1-year follow-up, all participants will undergo laboratory re-examination to observe the impact of follow-up CCTA on lipid target achievement. After 3 years of follow-up, the differences in the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) between the two groups will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 80 years old;\n2. Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);\n3. Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.\n\nExclusion Criteria:\n\n1. Patients who have experienced ACS or PCI/CABG;\n2. Patients who have experienced adverse cardiovascular and cerebrovascular events;\n3. Patients who have undergone follow-up CCTA or DSA examinations before enrollment;\n4. Patients with severe hepatic and renal dysfunction;\n5. Patients with contraindications to CCTA examinations;\n6. Patients with poor initial CCTA image quality or data loss.'}, 'identificationModule': {'nctId': 'NCT06843005', 'acronym': 'SUCCESS', 'briefTitle': 'Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2024DZKY-132-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CCTA-based follow-up management group', 'description': 'The subjects will undergo routine clinical and laboratory examinations, as well as follow-up CCTA examinations to assess the progression of plaques and to recommend appropriate management, treatment, and follow-up based on the findings', 'interventionNames': ['Diagnostic Test: Coronary Computed Tomography Angiography']}, {'type': 'SHAM_COMPARATOR', 'label': 'clinical-based follow-up management group', 'description': 'The subjects will undergo routine clinical and laboratory examinations, and recommendations for appropriate management, treatment, and follow-up will be made based on the results.', 'interventionNames': ['Other: Current clinical guidelines']}], 'interventions': [{'name': 'Coronary Computed Tomography Angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Based on the assessment of plaque progression after follow-up CCTA examination, patients will be given either intensive treatment or routine treatment.', 'armGroupLabels': ['CCTA-based follow-up management group']}, {'name': 'Current clinical guidelines', 'type': 'OTHER', 'description': 'Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.', 'armGroupLabels': ['clinical-based follow-up management group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210018', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Longjiang Zhang, MD', 'role': 'CONTACT', 'email': 'kevinzhlj@163.com', 'phone': '13405833176'}, {'name': 'Chao Li, MD', 'role': 'CONTACT', 'email': 'lclive123123@163.com', 'phone': '18822060230'}], 'facility': 'Research Institute Of Medical Imaging Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Longjiang Zhang, MD', 'role': 'CONTACT', 'email': 'kevinzhlj@163.com', 'phone': '13405833167'}], 'overallOfficials': [{'name': 'Trail Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Jinling Hospital,Nanjing University School of Medicine,Nanjing,China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhang longjiang,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator : Zhang longjiang', 'investigatorFullName': 'Zhang longjiang,MD', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}