Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction

NCT06156319 | Unknown

• 1 other identifier: 2023MSXM019
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• MACE

  all-cause death, cardiac death, and nonfatal myocardial infarction.

  2 years

Study Arms (2)

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

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

Interventions

No intervention OTHER

No intervention

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosing patients with AMI.

You may qualify if:

• Patients diagnosed with AMI received PCI.

You may not qualify if:

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

Sponsors & Collaborators

• Yang Jing: lead

Related Publications (1)

• 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.

  PMID: 35704087 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: December 20, 2023
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share