NCT02505217

Brief Summary

Treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death. Because new drugs have increased treatment options, the development of tests that can guide treatment should improve treatment selection and further reduce the risk of cardiovascular events as well as bleeding. This study is designed to assess the value of new tests. It is a prospective study that will enroll patients who have had a heart attack. Blood will be taken during hospitalization for a heart attack (1 day after their heart attack) and a second time 6 months later during an ambulatory clinical visit. Investigators will perform biochemical tests on the blood that assess the likelihood of making blood clots. One tablespoon of blood will be taken at each time. Taking this amount of blood poses no risk to the participant. Investigators will ask the participant whether they have had bleeding or cardiovascular events during the initial evaluation, the ambulatory follow-up at 6 months, and during a telephone interview 1 year after enrollment. During their 1 year of participation, investigators will review medical records and record information in a manner that protects the identity of all participants. We hypothesize that the biochemical test results will be similar at baseline and 6 month follow-up and that these biochemical tests will identify patients at greater risk of cardiovascular events and bleeding. Treatment of participants will not be altered by their participation in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 13, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

July 21, 2015

Results QC Date

April 19, 2019

Last Update Submit

May 12, 2020

Conditions

Myocardial Infarction

Keywords

platelet reactivity, thrombin generation

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Event - Myocardial Infarction, Stroke, Death

    number of participants with myocardial infarction, stroke, and/or death

    average duration of follow-up 19 months

Secondary Outcomes (1)

  • Bleeding

    1 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

acute myocardial infarction

You may qualify if:

  • Myocardial infarction demonstrated by elevated markers of cardiac injury (troponin I (TNI) or creatine kinase (CK) MB fraction)
  • the presence of coronary artery disease demonstrated by cardiac catheterization or perfusion imaging

You may not qualify if:

  • Treatment with long term anticoagulants
  • active infection
  • malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (3)

  • Schneider DJ, McMahon SR, Ehle GL, Chava S, Taatjes-Sommer HS, Meagher S. Assessment of Cardiovascular Risk by the Combination of Clinical Risk Scores Plus Platelet Expression of FcgammaRIIa. Am J Cardiol. 2020 Mar 1;125(5):670-672. doi: 10.1016/j.amjcard.2019.12.008. Epub 2019 Dec 9.

    PMID: 31883679DERIVED

  • McMahon SR, Chava S, Taatjes-Sommer HS, Meagher S, Brummel-Ziedins KE, Schneider DJ. Variation in platelet expression of FcgammaRIIa after myocardial infarction. J Thromb Thrombolysis. 2019 Jul;48(1):88-94. doi: 10.1007/s11239-019-01852-7.

    PMID: 30968301DERIVED

  • Schneider DJ, McMahon SR, Chava S, Taatjes-Sommer HS, Meagher S, Ehle GL, Brummel-Ziedins KE. FcgammaRIIa: A New Cardiovascular Risk Marker. J Am Coll Cardiol. 2018 Jul 10;72(2):237-238. doi: 10.1016/j.jacc.2018.04.046. No abstract available.

    PMID: 29976297DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for measuring clot generation, coagulation factors, and platelet measures

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
David J Schneider, MD
Organization
University of Vermont
david.schneider@uvm.edu
802-656-8955

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 22, 2015

Study Start

July 1, 2015

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

May 13, 2020

Results First Posted

May 13, 2020

Record last verified: 2020-05

Locations

US(1)