NSTEMI, STEMI
Conditions
Keywords
biomarker, platelet, prognosis, cardiovascular
Brief summary
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.
Interventions
DIAGNOSTIC_TESTProlocor pFCG test
Perform pFCG test on patients admitted with myocardial infarction to assess prognosis
Sponsors
Prolocor, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic | Study Duration (up to 3 years) | compare the hazard ratio for first occurrence of myocardial infarction (MI), stroke and death in patients with high vs low platelet FcGammaRIIa |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk Score | Study Duration (up to 3 years) | • Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death |
| Bleeding | Study Duration (up to 3 years) | compare the hazard ratio for first occurrence of bleeding (bleeding academic research consortium 2, 3, and 5) in patients with high vs low platelet FcGammaRIIa |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Myocardial Infarction Adults (age\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \
10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years. | 764 |
| Total | 764 |
Baseline characteristics
| Characteristic | Patients With Myocardial Infarction |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 567 Participants |
| Age, Categorical Between 18 and 65 years | 197 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 98 Participants |
| Race (NIH/OMB) More than one race | 50 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 595 Participants |
| Sex: Female, Male Female | 245 Participants |
| Sex: Female, Male Male | 519 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 22 / 764 |
| other Total, other adverse events | 0 / 764 |
| serious Total, serious adverse events | 0 / 764 |
Outcome results
Primary
Ischemic
compare the hazard ratio for first occurrence of myocardial infarction (MI), stroke and death in patients with high vs low platelet FcGammaRIIa
Time frame: Study Duration (up to 3 years)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Myocardial Infarction | Ischemic | MI, stroke, and death | 2.09 Hazard Ratio comparing high and low pFCG |
| Patients With Myocardial Infarction | Ischemic | MI and death | 2.71 Hazard Ratio comparing high and low pFCG |
| Patients With Myocardial Infarction | Ischemic | MI | 3.24 Hazard Ratio comparing high and low pFCG |
| Patients With Myocardial Infarction | Ischemic | death | 2.57 Hazard Ratio comparing high and low pFCG |
Secondary
Bleeding
compare the hazard ratio for first occurrence of bleeding (bleeding academic research consortium 2, 3, and 5) in patients with high vs low platelet FcGammaRIIa
Time frame: Study Duration (up to 3 years)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Myocardial Infarction | Bleeding | 1.84 Hazard Ratio comparing high and low pFCG |
Secondary
Risk Score
• Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death
Time frame: Study Duration (up to 3 years)