Clinical Research Details

Clinical Research

Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa (20211492)

Study Description

The study sponsor, Prolocor, has developed an investigational test that is designed to guide individualized care in patients who have had a heart attack. Patients that have had a heart attack are at heightened risk of heart attack and stroke in the future. 

800 patients who have had a heart attack will be enrolled in the trial overall to determine whether the test can identify patients who are at a higher risk of heart attack or stroke in the future. 

 

Inclusion/Exclusion Criteria

Inclusions:

1. Male or female subjects ≥ 18 years of age hospitalized with confirmed type 1 MI (STEMI or NSTEMI), referred to as the index event (described in Appendix 1).
2. Must have ≥ 2 of the following risk factors:
a) Age ≥ 65
b) Multi-vessel coronary artery disease (MVD) defined as ≥2 vessels or left main with a stenosis ≥50%
c) Chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) ? 60 ml/min/1.73 m2
d) Diabetes mellitus (DM)
e) 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

 

Exclusions:

1. 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.
2. Non-cardiovascular conditions that, in the judgment of the investigator, will limit survival to less than 2 years

Investigators