Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 12:01 PM
Study NCT ID:
NCT04987268
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2021-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHIP and Residual Cardiovascular Event Tendency After Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082182', 'term': 'Clonal Hematopoiesis'}], 'ancestors': [{'id': 'D006410', 'term': 'Hematopoiesis'}, {'id': 'D002454', 'term': 'Cell Differentiation'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D060965', 'term': 'Clonal Evolution'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1029}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2021-07-28', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of CHIP mutations', 'timeFrame': '24 hours', 'description': 'Whole-exome sequencing is performed to detect the presence of CHIP mutations'}], 'secondaryOutcomes': [{'measure': 'MACCE', 'timeFrame': '1 year', 'description': 'MACCE includes cardiac death, non-fatal MI, non-fatal stroke, rehospitalization due to heart failure, ischemia-driven revascularization at 12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACS', 'Clonal Hematopoiesis of Indeterminate Potential', 'Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'In order to identify the association between clonal hematopoiesis of indeterminate potential (CHIP) and cardiovascular risks after smoking cessation, this study intends to recruit ACS patients undergoing complete revascularization and perform whole-exome sequencing for enrolled patients to identify the prevalence of CHIP mutations. After 1-year follow-up, the relationship of presence of CHIP mutations and the occurrence of MACCEs will be explored, irrespective of smoking cessation or not. CHIP may be a potential risk factor of poor prognosis of ACS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ACS patients undergoing complete revascularization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. In-patients with acute coronary syndrome to undergo PCI 2. Complete revascularization during the index hospitalization 3. Written informed consent\n\nExclusion Criteria:\n\n* 1\\. Periprocedural complications (coronary artery dissection, perforation, myocardial infarction, stroke, death) 2. Planned coronary revascularization at discharge 3. Patients with severe chronic disease (uremia, liver cirrhosis, COPD (chronic obstructive pulmonary disease) 4. Abnormal blood counts caused by hematological diseases 5. Diagnosed malignancy'}, 'identificationModule': {'nctId': 'NCT04987268', 'acronym': 'CHIP-RETENTION', 'briefTitle': 'CHIP and Residual Cardiovascular Event Tendency After Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Shenyang Northern Hospital'}, 'officialTitle': 'Clonal Hematopoiesis of Indeterminate Potential and Residual Cardiovascular Event Tendency After Smoking Cessation', 'orgStudyIdInfo': {'id': 'CHIP RETENTION V1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Current-smoking', 'description': 'exposure: smoking', 'interventionNames': ['Genetic: clonal hematopoiesis of indeterminate potential']}, {'label': 'Smoking-cessation', 'description': 'exposure: smoking cessation', 'interventionNames': ['Genetic: clonal hematopoiesis of indeterminate potential']}, {'label': 'non-smoking', 'description': 'exposure: none', 'interventionNames': ['Genetic: clonal hematopoiesis of indeterminate potential']}], 'interventions': [{'name': 'clonal hematopoiesis of indeterminate potential', 'type': 'GENETIC', 'description': 'Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)', 'armGroupLabels': ['Current-smoking', 'Smoking-cessation', 'non-smoking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'General Hospital of Shenyang Military Region', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Yaling Han, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The General Hospital of Northern Theater Command'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenyang Northern Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of cardiology, Shenyang Northern Hospital', 'investigatorFullName': 'Han Yaling', 'investigatorAffiliation': 'Shenyang Northern Hospital'}}}}