Clinical trial NCT02106429: Platelet Activity in Vascular Surgery and Cardiovascular Events
Official title: Platelet Activity in Vascular Surgery and Cardiovascular Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Peripheral Artery Disease
Critical Limb Ischemia
Keywords: Vascular Surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-04-08
Enrollment: 246
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study's population will be obtained form NYU Langone Medical Center, Bellevue Hospital and the VA Hospital.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects undergoing non emergent lower extremity revascularization
2. Use of aspirin within 48 hours prior to surgery
3. Age \> 21 years of age
4. Able and willing to provide written informed consent for the study

Exclusion Criteria:

1. Use of any therapeutic anticoagulant
2. Use of any nonsteroidal antiinflammatory drug (ibuprofen, naproxen, etc.) within 72 hours
3. Thrombocytopenia (platelet count\<100) or Thrombocytosis (platelet count\>500)
4. Anemia (hemoglobin\<9)
5. Any known hemorrhagic diathesis

Primary outcomes:
measure: Number of Patients in Which Platelet Activity Measurements Were Associated With Short-term Cardiovascular Events
timeFrame: 30-days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center and School of Medicine
state: New York
Study officials:
affiliation: New York University Director of Cardiovascular Thrombosis
name: Jeffrey Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.