Clonal Hematopoiesis on Prognosis in Patients With Myocardial Infarction

NCT ID: NCT06156319

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-20

Study Completion Date

2025-06-20

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type 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

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients diagnosed with AMI received PCI.

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yang Jing

OTHER

Sponsor Role lead

Responsible Party

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Yang Jing

physician

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 35704087 (View on PubMed)

Other Identifiers

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2023MSXM019

Identifier Type: -

Identifier Source: org_study_id