Platelet Activity in Vascular Surgery and Cardiovascular Events

NCT02106429 | Completed Results DMC

• 2 other identifiers: 14-00531R01HL114978
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiovascular Disease; Peripheral Artery Disease; Critical Limb Ischemia

Keywords

Vascular Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Medical Center and School of Medicine

New York, New York, 10016, United States

Location

Related Publications (2)

• 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.

  PMID: 40126944 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.

  PMID: 29301628 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Cardiovascular Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Results Point of Contact

• Title: Jeffrey Berger, MD
• Organization: NYU Langone Health

jeffrey.berger@nyulangone.org

212-263-4004

Study Officials

• Jeffrey Berger, MD

  New York University Director of Cardiovascular Thrombosis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2014
• Primary Completion: June 14, 2018
• Study Completion: June 14, 2018
• Last Updated: August 20, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Locations

US (1)