Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction

November 27, 2023 updated by: Yang Jing

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Diagnosing patients with AMI.

Description

Inclusion Criteria:

Patients diagnosed with AMI received PCI.

Exclusion Criteria:

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 2 years
all-cause death, cardiac death, and nonfatal myocardial infarction.
2 years

Collaborators and Investigators

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

Sponsor

Yang Jing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

December 20, 2023

Primary Completion (Estimated)

June 20, 2025

Study Completion (Estimated)

June 20, 2025

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Estimated)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023MSXM019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on To Investigate the Effect of CHIP on Renal Insufficiency in AMI Patients

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