Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05369702
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2022-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-14', 'size': 1119178, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-05-06T08:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-10', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Lewis and ABO blood group phenotypes in cases and controls.', 'timeFrame': 'Lewis and ABO phenotype of the study participants was determined immediately after sample collection', 'description': 'Prevalence Lewis and ABO phenotype in cases will be compared to prevalence of the same in controls.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ABO blood group system', 'Lewis negative phenotype', 'coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Primary objective- To study the association of Lewis antigen and A, B, O blood group phenotypes with coronary artery disease patients attending the tertiary care hospital in Kerala.\n\nThe secondary objective-To find the association of Lewis antigen and A, B, O blood group phenotypes with smoking, alcohol use, diabetes, hypertension and dyslipidemia.\n\nA case-control study to compare the prevalence of Lewis(a-b-) blood group among confirmed cardiac cases with the prevalence of the same among the general population and thereby find out if individuals with Lewis(a-b-) are more at risk of developing coronary artery disease. This may provide an economical and simple method for identifying subjects at increased risk for coronary artery disease and subsequently lead to more focused preventive measures and eventually to a specific treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '70 cases attending the Cardiology department who satisfy the inclusion and exclusion criteria were taken as cases.\n\n140 (age and gender-matched) healthy blood donors who were eligible to donate blood as per the inclusion and exclusion criteria of Drugs and Cosmetics Rules, 1945 were taken as controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients in the age group of 30-55 years at the time of data collection diagnosed with coronary artery disease based on positive changes in coronary angiogram (more than 70% coronary stenosis)\n\nExclusion Criteria:\n\n* Patients with other systemic illnesses like malignancy, autoimmune diseases.\n* Patients who were not willing to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05369702', 'briefTitle': 'Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes', 'organization': {'class': 'OTHER', 'fullName': 'Jubilee Mission Medical College and Research Institute'}, 'officialTitle': 'Association of Coronary Artery Disease With Lewis and ABO Blood Group Phenotypes- A Case Control Study', 'orgStudyIdInfo': {'id': '47/19/IEC/JMMC&RI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CASE(coronary artery disease)', 'description': 'Patients with confirmed coronary artery disease'}, {'label': 'CONTROL', 'description': 'People without coronary artery disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '680005', 'city': 'Thrissur', 'state': 'Kerala', 'country': 'India', 'facility': 'Jubilee Mission Medical College & Research Institute', 'geoPoint': {'lat': 10.51667, 'lon': 76.21667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jubilee Mission Medical College and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sree Raj V', 'investigatorAffiliation': 'Jubilee Mission Medical College and Research Institute'}}}}