Myocardial Infarction
Conditions
Keywords
platelet reactivity, thrombin generation
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.
Interventions
None listed
Sponsors
Janssen Research & Development, LLC
University of Vermont
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Event - Myocardial Infarction, Stroke, Death | average duration of follow-up 19 months | number of participants with myocardial infarction, stroke, and/or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | 1 year | number of participants with the occurrence of a bleeding event leading the participant to seek medical attention |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High FcγRIIa Expression Patients with platelet expression of FcγRIIa \>11,000/platelet | 104 |
| Low FcγRIIa Expression Patients with platelet expression of FcγRIIa \<11,000/platelet | 93 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Low FcγRIIa Expression | Total | High FcγRIIa Expression |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 11 | 63 years STANDARD_DEVIATION 12 | 65 years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 93 participants | 197 participants | 104 participants |
| Sex: Female, Male Female | 27 Participants | 58 Participants | 31 Participants |
| Sex: Female, Male Male | 66 Participants | 139 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 3 / 104 |
| other Total, other adverse events | 0 / 93 | 0 / 104 |
| serious Total, serious adverse events | 6 / 93 | 17 / 104 |
Outcome results
Primary
Cardiovascular Event - Myocardial Infarction, Stroke, Death
number of participants with myocardial infarction, stroke, and/or death
Time frame: average duration of follow-up 19 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High FcγRIIa Expression | Cardiovascular Event - Myocardial Infarction, Stroke, Death | 17 Participants |
| Low FcγRIIa Expression | Cardiovascular Event - Myocardial Infarction, Stroke, Death | 6 Participants |
p-value: 0.007Regression, Cox
Secondary
Bleeding
number of participants with the occurrence of a bleeding event leading the participant to seek medical attention
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High FcγRIIa Expression | Bleeding | 6 Participants |
| Low FcγRIIa Expression | Bleeding | 6 Participants |