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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Event - Myocardial Infarction, Stroke, Death | number of participants with myocardial infarction, stroke, and/or death | average duration of follow-up 19 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | number of participants with the occurrence of a bleeding event leading the participant to seek medical attention | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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acute myocardial infarction
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31883679 | Derived | 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. | |
| 30968301 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With MI and High FcGammaRIIa Expression | We enrolled patients after a myocardial infarction (MI) before discharge. Platelet expression of FcγRIIa was quantified with the use of flow cytometry - high expression was >11,000/platelet |
| FG001 | Patients With MI and Low FcGammaRIIa Expression | We enrolled patients after a myocardial infarction (MI) before discharge. Platelet expression of FcγRIIa was quantified with the use of flow cytometry - low expression was <11,000/platelet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High FcγRIIa Expression | Patients with platelet expression of FcγRIIa >11,000/platelet |
| BG001 | Low FcγRIIa Expression | Patients with platelet expression of FcγRIIa <11,000/platelet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Geometric Mean |
| 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 | Cardiovascular Event - Myocardial Infarction, Stroke, Death | number of participants with myocardial infarction, stroke, and/or death | Posted | Count of Participants | Participants | average duration of follow-up 19 months |
|
|
average duration of follow-up 19 months
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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 | Low Platelet Expression of FcGammaRIIa | Patients whose platelet expression of FcGammaRIIa was below 11,000 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MI | Cardiac disorders | Systematic Assessment | myocardial infarction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J Schneider, MD | University of Vermont | 802-656-8955 | david.schneider@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2015 | Apr 22, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Blood for measuring clot generation, coagulation factors, and platelet measures
| 29976297 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Bleeding | number of participants with the occurrence of a bleeding event leading the participant to seek medical attention | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 93 |
| 6 |
| 93 |
| 0 |
| 93 |
| EG001 | High Platelet Expression of FcGammaRIIa | Patients whose platelet expression of FcGammaRIIa was > 11,000 | 3 | 104 | 17 | 104 | 0 | 104 |
| stroke | Vascular disorders | Systematic Assessment | stroke |
|
| mortality | Investigations | Systematic Assessment | all cause mortality |
|
| revascularization | Cardiac disorders | Systematic Assessment | coronary revascularization |
|
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |