Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT07049302
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Conventional and Non-Conventional CRF and Their Association With Acute Coronary Syndrome
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-06-25', 'studyFirstSubmitQcDate': '2025-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Structured Smoking Questionnaire', 'timeFrame': '12 Months', 'description': "A structured smoking questionnaire is a tool used to assess an individual's smoking habits, level of nicotine dependence, and potential motivations for smoking. These questionnaires typically include questions about cigarette consumption, brand preferences, smoking patterns, and the perceived effects of smoking.\n\nnterpretation: Higher scores indicate greater nicotine dependence.\n\nScores:\n\n0-2: Very low dependence 3-4: Low dependence 5: Moderate dependence 6-7: High dependence 8-10: Very high dependence"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'This research aims to compare conventional and non-conventional cardiovascular risk factors and their association with Acute Coronary Syndrome (ACS). Conventional risk factors such as hypertension, diabetes mellitus, dyslipidemia, smoking, and family history are well-established contributors to ACS. However, emerging non-conventional risk factors-including elevated inflammatory markers , homocysteine levels, lipoprotein(a), psychological stress, and lifestyle factors-are gaining attention for their potential role in cardiovascular events.', 'detailedDescription': 'The study will involve a cross-sectional analysis of ACS patients, examining the prevalence and impact of both types of risk factors. By assessing their relative contributions, the study aims to enhance understanding of ACS pathogenesis, identify at-risk populations more accurately, and support more comprehensive prevention strategies. The findings may help broaden clinical risk assessment tools and guide personalized interventions to reduce the incidence of ACS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will involve a cross-sectional analysis of ACS patients, examining the prevalence and impact of both types of risk factors. By assessing their relative contributions, the study aims to enhance understanding of ACS pathogenesis, identify at-risk populations more accurately, and support more comprehensive prevention strategies. The findings may help broaden clinical risk assessment tools and guide personalized interventions to reduce the incidence of ACS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients diagnosed with ACS.\n* Patients providing informed consent for participation.\n\nExclusion Criteria:\n\n* Patients with chronic heart diseases unrelated to ACS.\n* Patients unable to provide consent due to critical illness.'}, 'identificationModule': {'nctId': 'NCT07049302', 'briefTitle': 'Comparison of Conventional and Non-Conventional CRF and Their Association With Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Comparison of Conventional and Non-Conventional Cardiovascular Risk Factors and Their Association With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'MSAHSW/Batch-Fall23/911'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional Risk Factor Assessment', 'interventionNames': ['Combination Product: Conventional Risk Factor Assessment']}, {'label': 'Non-Conventional Risk Factor', 'interventionNames': ['Combination Product: Non-Conventional Risk Factor']}], 'interventions': [{'name': 'Conventional Risk Factor Assessment', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants in Group 1 will undergo evaluation for conventional cardiovascular risk factors associated with Acute Coronary Syndrome (ACS', 'armGroupLabels': ['Conventional Risk Factor Assessment']}, {'name': 'Non-Conventional Risk Factor', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants in Group 2 will be assessed for non-conventional cardiovascular risk factors associated with Acute Coronary Syndrome (ACS).', 'armGroupLabels': ['Non-Conventional Risk Factor']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Tertiary care hospital', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}