Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction

Sponsor

Yang Jing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06156319

Collaborator

(none)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
To Investigate the Effect of CHIP on Renal Insufficiency in AMI Patients	Other: No intervention

Detailed Description

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

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multicentre Cohort Study on the Effect of Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction Based on Residual Inflammation Risk

Anticipated Study Start Date :

Dec 20, 2023

Anticipated Primary Completion Date :

Jun 20, 2025

Anticipated Study Completion Date :

Jun 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: No intervention 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	Other: No intervention No intervention

Arm

Intervention/Treatment

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.

Other: No intervention

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

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

MACE [2 years]
all-cause death, cardiac death, and nonfatal myocardial infarction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients diagnosed with AMI received PCI.

Exclusion Criteria:

patients with severe heart disease, severe liver and kidney insufficiency, pregnancy, etc.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Yang Jing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Yang Jing, physician, Chongqing Emergency Medical Center

ClinicalTrials.gov Identifier:

NCT06156319

Other Study ID Numbers:

2023MSXM019

First Posted:

Dec 5, 2023

Last Update Posted:

Dec 5, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Renal Insufficiency

Myocardial Infarction

Infarction

Study Results

No Results Posted as of Dec 5, 2023