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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL114978 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Pathological and clinical studies have consistently demonstrated that abnormalities in thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and atherothrombosis. Screening for abnormalities in thrombosis and hemostasis by measuring platelet activity, thrombin generation, and markers of coagulation have been proposed to identify individuals at high-risk for cardiovascular events, however, it remains a research tool not ready for implementation in standard care.
The proposed study will add to the growing understanding of platelet activity and markers of coagulation in cardiovascular disease; examine a comprehensive battery of platelet activity markers, thrombin generation, markers of coagulation, and inflammatory biomarkers in subjects undergoing vascular surgery; and will provide important data on the mechanism of increased platelet activity using micro RNA, RNA and DNA expression profiling. The study design is prospective and the main outcome measure is platelet activity measurements associated with short-term cardiovascular events in PAD patients
The main aim is to determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in Peripheral artery disease (PAD) patients undergoing open non-emergent lower extremity vascular surgery. We will characterize the platelet phenotype in 350 PAD patients before vascular surgery and use Cox proportional hazard models to determine the independent association of the platelet phenotype with risk of cardiovascular events in the first 30 days after surgery.
Blood collection at three different time points (before surgery, following surgery while still in the hospital, and at the subjects' first return visit to the vascular surgeon following surgery) will allow us to assess the dynamic change in platelet activity, coagulation and inflammation during the perioperative period. We believe that markers of clotting and bleeding will change during the course of surgery, and that some of these markers may be used to help predict the likelihood of developing a clotting or bleeding event following surgery. The long-term goal is to develop a clinically useful assessment of platelet activity, thrombin generation, coagulation and inflammation for risk stratification that may ultimately serve as a target for therapeutic intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Hyperactivity | Subjects with platelet hyperactivity undergoing non emergent lower extremity revascularization. | ||
| No Platelet Hyperactivity | Subjects with no platelet hyperactivity undergoing non emergent lower extremity revascularization. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Which Platelet Activity Measurements Were Associated With Short-term Cardiovascular Events | To determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in Peripheral artery disease (PAD) patients undergoing open non-emergent lower extremity vascular intervention. We will characterize the platelet phenotype in 350 PAD patients before vascular surgery and use Cox proportional hazard models to determine the independent association of the platelet phenotype with risk of cardiovascular events in the first 30 days after surgery. | 30-days |
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Inclusion Criteria:
Exclusion Criteria:
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The study's population will be obtained form NYU Langone Medical Center, Bellevue Hospital and the VA Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Berger, MD | New York University Director of Cardiovascular Thrombosis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center and School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40126944 | Derived | Sowa MA, Hannemann C, Pinos I, Ferreira E, Biwas B, Dai M, Corr EM, Cornwell MG, Drenkova K, Lee AH, Spruill T, Reynolds HR, Hochman JS, Ruggles KV, Campbell RA, van Solingen C, Wright MD, Moore KJ, Berger JS, Barrett TJ. Tetraspanin CD37 regulates platelet hyperreactivity and thrombosis. Cardiovasc Res. 2025 Jun 12;121(6):943-956. doi: 10.1093/cvr/cvaf051. | |
| 29301628 | Derived | Dann R, Hadi T, Montenont E, Boytard L, Alebrahim D, Feinstein J, Allen N, Simon R, Barone K, Uryu K, Guo Y, Rockman C, Ramkhelawon B, Berger JS. Platelet-Derived MRP-14 Induces Monocyte Activation in Patients With Symptomatic Peripheral Artery Disease. J Am Coll Cardiol. 2018 Jan 2;71(1):53-65. doi: 10.1016/j.jacc.2017.10.072. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet Hyperactivity | Subjects with platelet hyperactivity undergoing non emergent lower extremity revascularization. |
| FG001 | No Platelet Hyperactivity | Subjects with no platelet hyperactivity undergoing non emergent lower extremity revascularization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet Hyperactivity | Subjects with platelet hyperactivity undergoing non emergent lower extremity revascularization. |
| BG001 | No Platelet Hyperactivity | Subjects with no platelet hyperactivity undergoing non emergent lower extremity revascularization. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Number of Patients in Which Platelet Activity Measurements Were Associated With Short-term Cardiovascular Events | To determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in Peripheral artery disease (PAD) patients undergoing open non-emergent lower extremity vascular intervention. We will characterize the platelet phenotype in 350 PAD patients before vascular surgery and use Cox proportional hazard models to determine the independent association of the platelet phenotype with risk of cardiovascular events in the first 30 days after surgery. | Posted | Number | participants | 30-days |
|
30 days post surgery
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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 | Platelet Hyperactivity | Subjects with platelet hyperactivity undergoing non emergent lower extremity revascularization. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Berger, MD | NYU Langone Health | 212-263-4004 | jeffrey.berger@nyulangone.org |
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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 | Feb 11, 2022 | Jul 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Blood will be obtained from the patient using standard aseptic phlebotomy techniques at 3 time points throughout the study. This will be pre-operatively, at post-op day 2 and at the 30-day follow up. A questionnaire, urine specimen and endothelial function test will be performed as well.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| No Platelet Hyperactivity |
Subjects with no platelet hyperactivity undergoing non emergent lower extremity revascularization. |
|
|
| 0 |
| 203 |
| 0 |
| 203 |
| 0 |
| 203 |
| EG001 | No Platelet Hyperactivity | Subjects with no platelet hyperactivity undergoing non emergent lower extremity revascularization. | 1 | 43 | 0 | 43 | 0 | 43 |
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| D016491 |
| Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |