ACSCHIP-RETENTIONNCT04987268
CHIP and Residual Cardiovascular Event Tendency After Smoking Cessation
An observational study of ACS and Clonal Hematopoiesis of Indeterminate Potential, run by Shenyang Northern Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ACS, Clonal Hematopoiesis of Indeterminate Potential, Smoking Cessation
- What is being tested?
- clonal hematopoiesis of indeterminate potential
- How many people
- 1,029 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2021to 20 Aug 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ACS patients undergoing complete revascularization
Who may be able to join
- 1. In-patients with acute coronary syndrome to undergo PCI 2. Complete revascularization during the index hospitalization 3. Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Shenyang Military Region
Shenyang, Liaoning, 110016
About this study
Official title: 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.
- Being tested
- clonal hematopoiesis of indeterminate potential
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonal hematopoiesis of indeterminate potentialGenetic
Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)
| Study group | Role | What they receive |
|---|---|---|
| Current-smoking | exposure: smoking Receives: Genetic: clonal hematopoiesis of indeterminate potential | |
| Smoking-cessation | exposure: smoking cessation Receives: Genetic: clonal hematopoiesis of indeterminate potential | |
| non-smoking | exposure: none Receives: Genetic: clonal hematopoiesis of indeterminate potential |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of CHIP mutations
Whole-exome sequencing is performed to detect the presence of CHIP mutations
Measured: 24 hours
Secondary outcomes (1)
MACCE
MACCE includes cardiac death, non-fatal MI, non-fatal stroke, rehospitalization due to heart failure, ischemia-driven revascularization at 12 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start20 Aug 2021
- Primary completion20 Aug 2022
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,029 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
- Investigators
- Yaling Han, MD, Study chair, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987268
- Sponsor's protocol ID
- CHIP RETENTION V1.0
- Acronym
- CHIP-RETENTION
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2021
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonal Hematopoiesis of Indeterminate Potential and Residual Cardiovascular Event Tendency After Smoking Cessation
- ClinicalTrials.gov ID
- NCT04987268
- Acronym / sponsor ID
- CHIP-RETENTION / CHIP RETENTION V1.0
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current-smoking | – | Genetic: clonal hematopoiesis of indeterminate potentialexposure: smoking |
| Smoking-cessation | – | Genetic: clonal hematopoiesis of indeterminate potentialexposure: smoking cessation |
| non-smoking | – | Genetic: clonal hematopoiesis of indeterminate potentialexposure: none |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ACS patients undergoing complete revascularization
Key inclusion criteria (1 listed)
- 1. In-patients with acute coronary syndrome to undergo PCI 2. Complete revascularization during the index hospitalization 3. Written informed consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clonal hematopoiesis of indeterminate potentialWhole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP) | Genetic | Current-smoking, Smoking-cessation, non-smoking |
Primary outcome
prevalence of CHIP mutations
Time frame: 24 hours
Whole-exome sequencing is performed to detect the presence of CHIP mutations
1 secondary outcome
MACCE
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaling Han, MD study chair
The General Hospital of Northern Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACS and Clonal Hematopoiesis of Indeterminate Potential, run by Shenyang Northern Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of CHIP mutations (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.