Platelet Activity in Vascular Surgery and Cardiovascular Events
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/7/2018 |
| Start Date: | March 2014 |
| End Date: | June 14, 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
New York, New York 10016
Principal Investigator: Jeffrey Berger, MD
Phone: 212-263-4172
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