Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-21 @ 1:52 AM
Study NCT ID:
NCT02471768
Status:
COMPLETED
Last Update Posted:
2015-06-17
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-09-29', 'releaseDate': '2015-08-31'}, {'resetDate': '2016-08-18', 'releaseDate': '2016-07-10'}, {'resetDate': '2018-02-20', 'releaseDate': '2017-08-13'}], 'estimatedResultsFirstSubmitDate': '2015-08-31'}}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 623}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-15', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2015-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute coronary syndrome(ACS)', 'timeFrame': '6 MONTHS'}, {'measure': 'stroke', 'timeFrame': '6 months'}, {'measure': 'revascularisation', 'timeFrame': '6 months'}, {'measure': 'death', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['central pressure', 'Gensini score', 'pulsatility', 'coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Abstract\n\nObjectives:\n\nPrimary: To study the association between central aortic blood pressure indices and coronary artery disease in patients undergoing elective angiography. Secondary: (a) To study whether any association exists between central aortic pressure indices and the incidence of major adverse cardiovascular events (MACE) in the same patients during a 6 month follow up period. (b) To study whether any association exists between the central aortic pressures and peripheral pressures.\n\nMethods: The investigators conducted a prospective observational study in consecutive patients undergoing coronary angiography. Central and peripheral pressures were invasively recorded and coronary artery disease (CAD) classified into obstructive and non-obstructive group. CAD severity was graded using the Gensini score and subjects were divided into tertiles. Patients were followed up and the role of central aortic pressure indices in the prediction of cardiovascular events were analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ALL CONSECUTIVE SUBJECTS UNDERGOING CORONARY ANGIOGRAM FOR THE DIAGNOSIS OF CAD DURING A 6 MONTH PERIOD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective angiography for diagnosis of CAD.\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Patients with acute myocardial infarction, unstable angina or thromboembolism in the preceding 3 months.\n* More than mild valvular heart disease.\n* Renal impairment with serum creatinine \\> 1.5 mg%.\n* Unable to obtain a full study of the coronary arteries.\n* Peripheral vascular occlusive disease.\n* Post coronary artery bypass grafting( CABG)\n* Heart rate \\< 50/min and \\> 120/min and other arrhythmias.\n* Contraindications for coronary angiography.\n* Unable to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT02471768', 'acronym': 'CAPCAD', 'briefTitle': 'The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Government Medical College, Kozhikode'}, 'officialTitle': 'The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'Ref No IRC/2013/Protocol/162'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS', 'type': 'PROCEDURE', 'description': 'coronary angiogram'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'SHREETAL R NAIR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Government Medical College, Kozhikode'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Medical College, Kozhikode', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Shreetal Rajan Nair', 'investigatorFullName': 'SHREETAL RAJAN NAIR', 'investigatorAffiliation': 'Government Medical College, Kozhikode'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-08-31', 'type': 'RELEASE'}, {'date': '2015-09-29', 'type': 'RESET'}, {'date': '2016-07-10', 'type': 'RELEASE'}, {'date': '2016-08-18', 'type': 'RESET'}, {'date': '2017-08-13', 'type': 'RELEASE'}, {'date': '2018-02-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'SHREETAL RAJAN NAIR, Dr Shreetal Rajan Nair, Government Medical College, Kozhikode'}}}}