Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

NCT05175261 | Completed Results

• 1 other identifier: PRL-0001
• Study Type: observational
• Target: 764
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI; NSTEMI

Keywords

biomarker; platelet; prognosis; cardiovascular

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Risk Score

  Study Duration (up to 3 years)

• Bleeding

  Study Duration (up to 3 years)

Interventions

Prolocor pFCG test DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• Requirement for treatment with full dose anticoagulant therapy (e.g., for atrial fibrillation)
• 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.
• Non-cardiovascular conditions that, in the judgment of the investigator, will limit survival to less than 2 years

Sponsors & Collaborators

• Prolocor, Inc: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

• 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.

  PMID: 40135363 RESULT

• 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.

  PMID: 39443015 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: David J Schneider, MD
• Organization: Prolocor, Inc

david.schneider@prolocor.com

8023730071

Study Officials

• David J Schneider, MD

  Prolocor, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 3, 2022
• Study Start: January 20, 2022
• Primary Completion: April 18, 2025
• Study Completion: May 22, 2025
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)