Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-03 @ 7:09 PM
Study NCT ID:
NCT04795492
Status:
WITHDRAWN
Last Update Posted:
2024-02-08
First Post:
2021-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Remote Intervention in Patients With SCAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'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'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to recruit enough patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2021-03-09', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication adherence', 'timeFrame': '1 year', 'description': 'Compliance and administration of cardiovascular protective drugs'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '1 year', 'description': 'BP was measured twice by an electronic device after 10 min of seated rest and calculated as the mean of 2 measurements'}, {'measure': 'Body Mass Index', 'timeFrame': '1 year', 'description': 'standard protocol'}, {'measure': 'LDL Cholesterol', 'timeFrame': '1 year', 'description': 'standard protocol'}, {'measure': 'HbA1c', 'timeFrame': '1 year', 'description': 'standard protocol'}, {'measure': 'Smoking', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'Drinking', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'Aspirin', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'P2Y12 receptor antagonist', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'Statin', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'ACEI/ARB', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'Beta-blocker', 'timeFrame': '1 year', 'description': 'self-reported'}, {'measure': 'MACCE', 'timeFrame': '1 year', 'description': 'acute myocardial infarction, acute heart failure, rehospitalization for cardiovascular event, stroke, death from any cause, death from a cardiovascular cause and unplanned revascularization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stable Chronic Angina', 'Ischemic Heart Disease', 'Coronary Artery Disease', 'Heart Diseases', 'Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '30998400', 'type': 'BACKGROUND', 'citation': 'Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.'}, {'pmid': '32745732', 'type': 'BACKGROUND', 'citation': 'Yu C, Liu C, Du J, Liu H, Zhang H, Zhao Y, Yang L, Li X, Li J, Wang J, Wang H, Liu Z, Rao C, Zheng Z; MISSION-2 Collaborative Group. Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization. Am Heart J. 2020 Oct;228:17-26. doi: 10.1016/j.ahj.2020.06.019. Epub 2020 Jul 4.'}, {'pmid': '32858284', 'type': 'BACKGROUND', 'citation': 'Chen X, Zhou X, Li H, Li J, Jiang H. The value of WeChat application in chronic diseases management in China. Comput Methods Programs Biomed. 2020 Nov;196:105710. doi: 10.1016/j.cmpb.2020.105710. Epub 2020 Aug 14.'}]}, 'descriptionModule': {'briefSummary': 'The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.', 'detailedDescription': "Objective: This study is intended to verify the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease.\n\nStudy design: The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up.\n\nStudy intervention: Participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. The control group had no special intervention. All patients received follow-up at 6 months and 1-year follow-up.\n\nOutcome measures: The primary outcome was medication adherence. Secondary outcomes included smoking, drinking, blood pressure, body mass index, LDL cholesterol, HbA1c, and major adverse cerebral cardiovascular events(MACCE). Medication compliance consists of the following five medications: aspirin, P2Y12 receptor antagonist, statin, ACEI/ARB and beta-blocker.\n\nStatistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged between 18-99 years\n2. Diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)\n3. Have sufficient Chinese language proficiency to reading, speaking and listening\n4. Live with at least one caregiver or guardian in the household\n5. Presence of stable hemodynamics without using vasopressor\n6. Able to individually consent\n7. Not participating in any other clinical trial\n\nExclusion Criteria:\n\n1. Unable to provide informed consent\n2. Unable to be involved in clinical follow-up and treatment\n3. Suffered comorbidity with a life expectancy of less than 1 year\n4. Have contra-indication to cardiac rehabilitation\n5. Acute coronary syndrome\n6. History of noncompliance with medical therapy\n7. Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial\n8. Planned major surgery necessitating interruption of antiplatelet therapy\n9. Inability to comply with the protocol\n10. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments'}, 'identificationModule': {'nctId': 'NCT04795492', 'briefTitle': 'Effect of Remote Intervention in Patients With SCAD', 'organization': {'class': 'OTHER', 'fullName': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}, 'officialTitle': 'Effect of Remote Intervention in Patients With SCAD', 'orgStudyIdInfo': {'id': 'ERIP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Remote intervention', 'interventionNames': ['Behavioral: remote intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Routine outpatient follow-up', 'interventionNames': ['Behavioral: Routine outpatient follow-up']}], 'interventions': [{'name': 'remote intervention', 'type': 'BEHAVIORAL', 'description': 'Medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided. Risk factor modification included lipid control, smoking and drinking cessation, BP monitoring, dietary change keeping a healthy weight and in our trial. There were also a lot of educational materials about coronary heart disease knowledge that were reviewed by cardiologists, and participants were free to provide them whenever and wherever they want.', 'armGroupLabels': ['Intervention group']}, {'name': 'Routine outpatient follow-up', 'type': 'BEHAVIORAL', 'description': 'Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Weihua Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuwai Hospital, Chinese Academy of Medical Science; National Center for Cardiovascular Diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Weihua Song', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences, Fuwai Hospital'}}}}