Platelet Activity in Vascular Surgery and Cardiovascular Events (PACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by New York University School of Medicine
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Jeffrey Berger, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02106429
First received: January 22, 2014
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition
Cardiovascular Disease
Peripheral Artery Disease
Critical Limb Ischemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Platelet Activity in Vascular Surgery and Cardiovascular Events

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Platelet activity measurements associated with short-term cardiovascular events in PAD patients [ Time Frame: 30-days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Association between platelet activity measurements and long-term cardiovascular events in patients with established PAD [ Time Frame: Average follow-up of 5-years ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • mRNA-microRNA co-expression profiles in patients with and without elevated platelet activity measurements [ Time Frame: 30-days ] [ Designated as safety issue: No ]
    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.


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.


Estimated Enrollment: 385
Study Start Date: March 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
PAD and CLI patients
Subjects undergoing non emergent lower extremity revascularization

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106429

Contacts
Contact: Edna Bissoon 2122634172 Edna.bissoon@nyumc.org
Contact: Adriana Perez 212-263-9493 Adriana.Perez@nyumc.org

Locations
United States, New York
NYU Langone Medical Center and School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Edna Bissoon    212-263-4172    edna.bissoon@nyumc.org   
Principal Investigator: Jeffrey Berger, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jeffrey Berger, MD New York University Director of Cardiovascular Thrombosis
  More Information

No publications provided

Responsible Party: Jeffrey Berger, Director of Cardiovascular Thrombosis, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02106429     History of Changes
Other Study ID Numbers: S14-00531, R01HL114978
Study First Received: January 22, 2014
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Vascular Surgery

Additional relevant MeSH terms:
Cardiovascular Diseases
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014