CHIP and Residual Cardiovascular Event Tendency After Smoking Cessation (CHIP-RETENTION)

August 2, 2021 updated by: Han Yaling, Shenyang Northern Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1029

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Shenyang Military Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ACS patients undergoing complete revascularization

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Current-smoking
exposure: smoking
Genetic: clonal hematopoiesis of indeterminate potential
Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)
Smoking-cessation
exposure: smoking cessation
Genetic: clonal hematopoiesis of indeterminate potential
Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)
non-smoking
exposure: none
Genetic: clonal hematopoiesis of indeterminate potential
Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of CHIP mutations
Time Frame: 24 hours
Whole-exome sequencing is performed to detect the presence of CHIP mutations
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE
Time Frame: 1 year
MACCE includes cardiac death, non-fatal MI, non-fatal stroke, rehospitalization due to heart failure, ischemia-driven revascularization at 12 months
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Investigators

  • Study Chair: Yaling Han, MD, The General Hospital of Northern Theater Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 20, 2021

Primary Completion (Anticipated)

August 20, 2023

Study Completion (Anticipated)

August 20, 2024

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CHIP RETENTION V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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