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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.
To describe platelet activity among PAD subjects undergoing vascular surgery.
To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events.
To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.
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| Measure | Description | Time Frame |
|---|---|---|
| Platelet Activity | The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling. | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Events | Thrombotic and Bleeding events | Two-years |
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Inclusion Criteria:
Exclusion Criteria:
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Study Population will be selected from the inpatient setting at NYU Medical Center and Bellevue Hospital as well as the outpatient setting in the Faculty Group Practice.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey S Berger, MD, MS, FAHA, FACC | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Hospital Center, South Manhattan Healthcare Network | New York | New York | 10016 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22825411 | Background | Berger JS, Hiatt WR. Medical therapy in peripheral artery disease. Circulation. 2012 Jul 24;126(4):491-500. doi: 10.1161/CIRCULATIONAHA.111.033886. No abstract available. | |
| 23223800 | Background | Berger JS, Becker RC, Kuhn C, Helms MJ, Ortel TL, Williams R. Hyperreactive platelet phenotypes: relationship to altered serotonin transporter number, transport kinetics and intrinsic response to adrenergic co-stimulation. Thromb Haemost. 2013 Jan;109(1):85-92. doi: 10.1160/TH12-03-0202. Epub 2012 Dec 6. |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D058729 | Peripheral Arterial Disease |
| D016893 | Carotid Stenosis |
| D017544 | Aortic Aneurysm, Abdominal |
| D017545 | Aortic Aneurysm, Thoracic |
| D014947 | Wounds and Injuries |
| D016769 | Embolism and Thrombosis |
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
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serum, plasma, platelet RNA
| New York University School Of Medicine |
| New York |
| New York |
| 10016 |
| United States |
| 19691485 | Background | Chu SG, Becker RC, Berger PB, Bhatt DL, Eikelboom JW, Konkle B, Mohler ER, Reilly MP, Berger JS. Mean platelet volume as a predictor of cardiovascular risk: a systematic review and meta-analysis. J Thromb Haemost. 2010 Jan;8(1):148-56. doi: 10.1111/j.1538-7836.2009.03584.x. Epub 2009 Aug 19. |
| 22739687 | Background | Eraso LH, Fukaya E, Mohler ER 3rd, Xie D, Sha D, Berger JS. Peripheral arterial disease, prevalence and cumulative risk factor profile analysis. Eur J Prev Cardiol. 2014 Jun;21(6):704-11. doi: 10.1177/2047487312452968. Epub 2012 Jun 27. |
| 21562837 | Background | Sharma G, Berger JS. Platelet activity and cardiovascular risk in apparently healthy individuals: a review of the data. J Thromb Thrombolysis. 2011 Aug;32(2):201-8. doi: 10.1007/s11239-011-0590-9. |
| 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. |
| D001157 |
| Arterial Occlusive Diseases |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D001018 | Aortic Diseases |