CHIP and Residual Cardiovascular Event Tendency After Smoking Cessation

• Conditions: Clonal Hematopoiesis of Indeterminate Potential; ACS; Smoking Cessation
• Interventions: Genetic: clonal hematopoiesis of indeterminate potential

• Registration Number: NCT04987268
• Lead Sponsor: Shenyang Northern Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-28
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-02
• Last Update Submitted: 2021-08-02
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03
• Study Start: 2021-08-20
• Primary Completion: 2023-08-20
• Study Completion: 2024-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1029

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-smoking	clonal hematopoiesis of indeterminate potential	exposure: none
Current-smoking	clonal hematopoiesis of indeterminate potential	exposure: smoking
Smoking-cessation	clonal hematopoiesis of indeterminate potential	exposure: smoking cessation

Primary Outcome Measures

Name	Time	Method
prevalence of CHIP mutations	24 hours	Whole-exome sequencing is performed to detect the presence of CHIP mutations

Secondary Outcome Measures

Name	Time	Method
MACCE	1 year	MACCE includes cardiac death, non-fatal MI, non-fatal stroke, rehospitalization due to heart failure, ischemia-driven revascularization at 12 months

Trial Locations

Locations (1)

General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, Liaoning, China