NCT04987268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,029

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

August 20, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

July 28, 2021

Last Update Submit

September 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of CHIP mutations

    Whole-exome sequencing is performed to detect the presence of CHIP mutations

    24 hours

Secondary Outcomes (1)

  • MACCE

    1 year

Study Arms (3)

Current-smoking

exposure: smoking

Genetic: clonal hematopoiesis of indeterminate potential

Smoking-cessation

exposure: smoking cessation

Genetic: clonal hematopoiesis of indeterminate potential

non-smoking

exposure: none

Genetic: clonal hematopoiesis of indeterminate potential

Interventions

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

Current-smokingSmoking-cessationnon-smoking

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ACS patients undergoing complete revascularization

You may qualify if:

  • \. In-patients with acute coronary syndrome to undergo PCI 2. Complete revascularization during the index hospitalization 3. Written informed consent

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110016, China

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Clonal Hematopoiesis

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

HematopoiesisCell DifferentiationCell Physiological PhenomenaClonal EvolutionGenetic PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Yaling Han, MD

    The General Hospital of Northern Theater Command

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of cardiology, Shenyang Northern Hospital

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 3, 2021

Study Start

August 20, 2021

Primary Completion

August 20, 2022

Study Completion

August 20, 2023

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations