To Investigate the Effect of CHIP on Renal Insufficiency in AMI PatientsNCT06156319
Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction
An observational study of To Investigate the Effect of CHIP on Renal Insufficiency in AMI Patients, run by Yang Jing.
Trial summary
This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- To Investigate the Effect of CHIP on Renal Insufficiency in AMI Patients
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2023to 20 Jun 2025
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Diagnosing patients with AMI.
Who may be able to join
- Patients diagnosed with AMI received PCI.
Who cannot join
- patients with severe heart disease, severe liver and kidney insufficiency, pregnancy, etc.
About this study
Official title: A Multicentre Cohort Study on the Effect of Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction Based on Residual Inflammation Risk
This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients.
Part two: To investigate the effect of CHIP on cardiovascular outcomes in patients with AMI complicated with CKD stage II-IV nephropathy. Part three: To investigate the effects of CHIP on cardiovascular and renal outcomes in AMI patients with ESRD. Study endpoint: Primary end points: all-cause death, cardiac death, and nonfatal myocardial infarction. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure.
Read the detailed description
This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients.
Patients with confirmed AMI were divided into two groups based on eGFR values:
AMI+ normal renal function group (eGFR≥90 ml/min); AMI+ renal dysfunction group (eGFR < 90 ml/min). Main outcome measures: CHIP carrying frequency, expression levels of IL-1β, IL-6, CRP, TNF-α, NLRP3 and other inflammatory factors.
Part two: To investigate the effect of CHIP on cardiovascular outcomes in patients with AMI complicated with CKD stage II-IV nephropathy. Patients with confirmed AMI complicated with CKD stage II-IV were divided into two groups according to CHIP sequencing results: CHIP group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identifi ed as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Study endpoint: Primary endpoints: all-cause death, cardiac death, nonfatal myocardial infarction,50% decrease in eGFR, or ESKD. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure. Part III: To investigate the effects of CHIP on cardiovascular and renal outcomes in AMI patients with ESRD. Patients with confirmed AMI combined with ESRD were divided into two groups according to CHIP sequencing results: CHIP group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Study endpoint: Primary end points: all-cause death, cardiac death, and nonfatal myocardial infarction. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | CHIP group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identified as CHIP carriers by gene targeted sequencing.
Non-chip group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Receives: Other: No intervention | |
| Group 2 | CHIP group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as CHIP carriers by gene targeted sequencing Non-chip group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
all-cause death, cardiac death, and nonfatal myocardial infarction.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Investigate the Effect of CHIP on Renal Insufficiency in AMI PatientsStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Jing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Jing, Chongqing Emergency Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156319
- Sponsor's protocol ID
- 2023MSXM019
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang Z, Li Y, Yan C, Zhang X, Zhang Q, Li J, Tian X, Qiu M, Liang Z, Ma S, Na K, Li Z, Chen S, Zhao Y, Qi Z, Liu X, Han Y. Clonal hematopoiesis of indeterminate potential in patients with acute coronary syndrome undergoing percutaneous coronary intervention in the absence of traditional risk factors. Clin Res Cardiol. 2023 Apr;112(4):506-517. doi: 10.1007/s00392-022-02039-6. Epub 2022 Jun 15.
PubMed 35704087
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Cohort Study on the Effect of Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction Based on Residual Inflammation Risk
- ClinicalTrials.gov ID
- NCT06156319
- Acronym / sponsor ID
- 2023MSXM019
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yang JingUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 5 Dec 2023 (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.
This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients.
Part two: To investigate the effect of CHIP on cardiovascular outcomes in patients with AMI complicated with CKD stage II-IV nephropathy. Part three: To investigate the effects of CHIP on cardiovascular and renal outcomes in AMI patients with ESRD. Study endpoint: Primary end points: all-cause death, cardiac death, and nonfatal myocardial infarction. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure.
Detailed description
This is an observational study without intervention. It is planned to include 500 patients with AMI from October 2023 to July 2026.The study was divided into three parts. Part I: To investigate the effect of CHIP on renal insufficiency in AMI patients.
Patients with confirmed AMI were divided into two groups based on eGFR values:
AMI+ normal renal function group (eGFR≥90 ml/min); AMI+ renal dysfunction group (eGFR < 90 ml/min). Main outcome measures: CHIP carrying frequency, expression levels of IL-1β, IL-6, CRP, TNF-α, NLRP3 and other inflammatory factors.
Part two: To investigate the effect of CHIP on cardiovascular outcomes in patients with AMI complicated with CKD stage II-IV nephropathy. Patients with confirmed AMI complicated with CKD stage II-IV were divided into two groups according to CHIP sequencing results: CHIP group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identifi ed as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Study endpoint: Primary endpoints: all-cause death, cardiac death, nonfatal myocardial infarction,50% decrease in eGFR, or ESKD. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure. Part III: To investigate the effects of CHIP on cardiovascular and renal outcomes in AMI patients with ESRD. Patients with confirmed AMI combined with ESRD were divided into two groups according to CHIP sequencing results: CHIP group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. Study endpoint: Primary end points: all-cause death, cardiac death, and nonfatal myocardial infarction. Secondary endpoints: angina pectoris requiring hospitalization, nonfatal stroke, and nonfatal heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No interventionCHIP group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identified as CHIP carriers by gene targeted sequencing. Non-chip group: Patients diagnosed with AMI combined with CKD stage II-IV underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing. |
| Group 2 | – | Other: No interventionCHIP group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as CHIP carriers by gene targeted sequencing Non-chip group: Patients diagnosed with AMI combined with ESRD underwent PCI and were identified as non-CHIP carriers by gene targeted sequencing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diagnosing patients with AMI.
Key inclusion criteria (1 listed)
- Patients diagnosed with AMI received PCI.
Key exclusion criteria (1 listed)
- patients with severe heart disease, severe liver and kidney insufficiency, pregnancy, etc.
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 |
|---|---|---|
| No interventionNo intervention | Other | Group 1, Group 2 |
Primary outcome
MACE
Time frame: 2 years
all-cause death, cardiac death, and nonfatal myocardial infarction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 35704087Jiang Z, Li Y, Yan C, Zhang X, Zhang Q, Li J, Tian X, Qiu M, Liang Z, Ma S, Na K, Li Z, Chen S, Zhao Y, Qi Z, Liu X, Han Y. Clonal hematopoiesis of indeterminate potential in patients with acute coronary syndrome undergoing percutaneous coronary intervention in the absence of traditional risk factors. Clin Res Cardiol. 2023 Apr;112(4):506-517. doi: 10.1007/s00392-022-02039-6. Epub 2022 Jun 15.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of To Investigate the Effect of CHIP on Renal Insufficiency in AMI Patients, run by Yang Jing.
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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
MACE (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06156319, which also lists 1 linked publication.
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 5 Dec 2023.