Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

764 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-20

Study Completion Date

2025-05-22

Brief Summary

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This is a Prospective, Observational Multicenter Non-Interventional Cohort Study. The primary objective is to determine whether platelet expression of FcγRIIa is associated with risk of myocardial infarction (MI), stroke and death. Secondary objectives include: 1) Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death; and 2) Determine whether platelet expression of FcγRIIa is associated with risk of major bleeding. The primary endpoint is the composite of death, MI and stroke. A secondary endpoint is the incidence of clinically significant bleeding according to the Bleeding Academic Research Consortium (BARC) scale type 2-5. Approximately 800 male and female subjects with confirmed MI \[ST-segment elevation MI (STEMI) or non-ST-segment elevation MI (NSTEMI)\] will be enrolled before hospital discharge for the index event. Approximately 10 sites in the United States will participate in this study. It is anticipated that it will take approximately 12 months to enroll approximately 800 subjects. The study and subject follow-up will continue until 1) at least 80 ischemic events (MI, stroke, and death) have occurred, and 2) the last subject enrolled has completed 18 months of follow-up.

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Detailed Description

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Conditions

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STEMI NSTEMI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Prolocor pFCG test

Perform pFCG test on patients admitted with myocardial infarction to assess prognosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Type 1 Myocardial Infarction (STEMI and NSTEMI)
2. Must have ≥ 2 of the following risk factors:

1. Age ≥ 65
2. Multi-vessel coronary artery disease (MVD) defined as ≥2 vessels or left main with a stenosis ≥50%
3. Chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) ˂ 60 mL/min/1.73 m2
4. Diabetes mellitus (DM)
5. Prior MI
3. Must agree to participate in the study, to comply with all study procedures and follow-up contact
4. Signed the informed consent form

Exclusion Criteria

1. Requirement for treatment with full dose anticoagulant therapy (e.g., for atrial fibrillation)
2. Participation in another trial in which the subject is known to receive or could receive anticoagulant or antiplatelet treatment as part of the trial intervention.
3. Non-cardiovascular conditions that, in the judgment of the investigator, will limit survival to less than 2 years

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No