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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolocor pFCG test | Diagnostic Test | Perform pFCG test on patients admitted with myocardial infarction to assess prognosis |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic | compare the hazard ratio for first occurrence of myocardial infarction (MI), stroke and death in patients with high vs low platelet FcGammaRIIa | Study Duration (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Score | • Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death | Study Duration (up to 3 years) |
| Bleeding |
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Inclusion Criteria:
Type 1 Myocardial Infarction (STEMI and NSTEMI)
Must have ≥ 2 of the following risk factors:
Must agree to participate in the study, to comply with all study procedures and follow-up contact
Signed the informed consent form
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| David J Schneider, MD | Prolocor, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40135363 | Result | Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff AC, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM; Investigators. Predictive Value of Platelet FcgammaRIIa in Patients Treated With PCI Compared With Medical Therapy Alone After Myocardial Infarction. Circ Cardiovasc Interv. 2025 Apr;18(4):e014939. doi: 10.1161/CIRCINTERVENTIONS.124.014939. Epub 2025 Mar 26. | |
| 39443015 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ischemic | compare the hazard ratio for first occurrence of myocardial infarction (MI), stroke and death in patients with high vs low platelet FcGammaRIIa | Posted | Number | 95% Confidence Interval | Hazard Ratio comparing high and low pFCG | Study Duration (up to 3 years) |
|
Adverse events were collected through study completion, an average of 21 months
Myocardial infarction, stroke, bleeding, and death were study endpoints and so were not considered adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J Schneider, MD | Prolocor, Inc | 8023730071 | david.schneider@prolocor.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2022 | May 24, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2023 | May 24, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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
| Study Duration (up to 3 years) |
| Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff A, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM. Platelet FcgammaRIIa as a Marker of Cardiovascular Risk After Myocardial Infarction. J Am Coll Cardiol. 2024 Oct 29;84(18):1721-1729. doi: 10.1016/j.jacc.2024.08.051. |
| 42304546 | Derived | Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff AC, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM; behalf of the investigators. Platelet FcɣRIIa Expression Refines Clinical Risk Assessment After Myocardial Infarction. Catheter Cardiovasc Interv. 2026 Jun 16. doi: 10.1002/ccd.70691. Online ahead of print. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Risk Score | • Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death | Not Posted | Study Duration (up to 3 years) | Participants |
| 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 | Posted | Number | 95% Confidence Interval | Hazard Ratio comparing high and low pFCG | Study Duration (up to 3 years) |
|
|
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| 22 |
| 764 |
| 0 |
| 764 |
| 0 |
| 764 |
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| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |