Platelet Activity in Vascular Surgery and Cardiovascular Events

Cardiovascular Disease Clinical Trial

— PACE  

Official title:

Platelet Activity in Vascular Surgery and Cardiovascular Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106429
• Other study ID #: 14-00531
• Secondary ID: R01HL114978
• Status: Completed
• Start date: March 2014
• Est. completion date: June 14, 2018

Study information

• Verified date: December 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 measures are platelet activity, coagulation markers and incident cardiovascular and bleeding events.

Description:

The main aim is to determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in 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. The next aim is to determine whether platelet activity measurements are independently associated with long-term cardiovascular events in patients with established PAD. We will characterize the platelet phenotype following surgery and use Cox proportional hazards models to determine the independent association of the platelet phenotype with risk of long-term composite of myocardial infarction, stroke, or all-cause mortality with a mean follow-up of 2-years following vascular surgery. The final goal is to investigate mRNA-microRNA co-expression profiles in patients with and without elevated platelet activity measurements. We will establish the relationship between differentially expressed microRNAs and their target mRNAs related to platelet activity and identify new diagnostic markers and potential therapeutic targets of increased platelet activity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: June 14, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
United States	NYU Langone Medical Center and School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mRNA-microRNA co-expression profiles in patients with and without elevated platelet activity measurements	To investigate mRNA-microRNA co-expression profiles in patients with and without elevated platelet activity measurements. We will establish the relationship between differentially expressed microRNAs and their target mRNAs related to platelet activity and thus identify new diagnostic markers and potential therapeutic targets of increased platelet activity.	30-days
Primary	Platelet activity measurements associated with short-term cardiovascular events in PAD patients	To determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in 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
Secondary	Association between platelet activity measurements and long-term cardiovascular events in patients with established PAD	To determine whether platelet activity measurements are independently associated with long-term cardiovascular events in patients with established PAD. We will characterize the postoperative platelet phenotype following surgery and use Cox proportional hazards models to determine the independent association of the platelet phenotype with risk of long-term composite of myocardial infarction, stroke, or all-cause mortality with a mean follow-up of 2-years following vascular surgery.	Average follow-up of 5-years