Clinical trial NCT02505217: Novel Biomarkers of Thrombotic Risk
Official title: Novel Biomarkers of Thrombotic Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: platelet reactivity, thrombin generation
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Janssen Research & Development, LLC
First posted: 2015-07-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acute myocardial infarction

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Treatment with long term anticoagulants
* active infection
* malignancy

Primary outcomes:
measure: Cardiovascular Event - Myocardial Infarction, Stroke, Death
timeFrame: average duration of follow-up 19 months
Secondary outcomes:
measure: Bleeding
timeFrame: 1 year
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.