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NCT04987268 Clinical Trial

CHIP and Residual Cardiovascular Event Tendency After Smoking Cessation

Smoking Cessation Clinical Trial

— CHIP-RETENTION  

Official title:
Clonal Hematopoiesis of Indeterminate Potential and Residual Cardiovascular Event Tendency After Smoking Cessation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04987268
Other study ID # CHIP RETENTION V1.0
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 20, 2021
Est. completion date August 20, 2024

Study information
Verified date August 2021
Source Shenyang Northern Hospital
Contact Jing Li, MD
Phone 13352452889
Email lijing790126@sina.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1029
Est. completion date August 20, 2024
Est. primary completion date August 20, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 1. In-patients with acute coronary syndrome to undergo PCI 2. Complete revascularization during the index hospitalization 3. Written informed consent Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• clonal hematopoiesis of indeterminate potential
Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)

Locations
Country Name City State
China General Hospital of Shenyang Military Region Shenyang Liaoning

Sponsors (1)
Lead Sponsor Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence of CHIP mutations Whole-exome sequencing is performed to detect the presence of CHIP mutations 24 hours
Secondary MACCE MACCE includes cardiac death, non-fatal MI, non-fatal stroke, rehospitalization due to heart failure, ischemia-driven revascularization at 12 months 1 year
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