peripheral arterial disease study
Protocol: STUDY00003967
Full Title
Validation of Plateletcrit as a marker of platelet reactivity and its effect on outcomes of lower extremity endovascular interventions
Description
This study enrolls adults with peripheral arterial disease (PAD; blocked arteries in the legs) who are having a lower extremity endovascular intervention (EVI). The purpose of the study is to learn how well a blood test called Plateletcrit find blood clotting cells. We want to see if this test might be useful to learn about outcomes for this surgery.

You will be in this study for about 15 months. You will give 3 blood samples in addition to routine blood testing. The remainder of your care
will remain unchanged. You will come for follow up visits as determined by your vascular surgeon. Your surgeon will perform a complete history and physical and may order pictures using ultrasound to evaluate blood flow to your legs. Study takes place at Erie County Medical Center (ECMC), Buffalo General
Medical Center (BGMC) and Gates Vascular Institute (GVI).

Technical Description

(CSR#190818782018) The proposed study addresses the increasing need to improve post-intervention outcomes in patients with peripheral arterial disease (PAD). PAD currently affects up to 12 million Americans, and that number is expected to reach 19 million by 2050. These patients are at increased risk of limb loss, cardiovascular morbidity, and mortality. Furthermore, failed revascularization interventions are associated with impaired ambulation and increased risk of amputation. With growing evidence that platelet reactivity may be predictive of a patients risk for treatment failure, our long-term goal is to utilize a platelet reactivity metric to tailor post-intervention antiplatelet therapy in PAD patients, leading to improved outcomes. The project proposed in this application will focus on testing plateletcrit (PCT) as a possible platelet reactivity (PR) metric that is readily available, inexpensive, and easily incorporated into standard care protocols.The aims of this study are: (1) to analyze the relationship between PCT and platelet reactivity as determined by the well-established VerifyNow platelet reactivity assay; (2) to determine the effect of high platelet reactivity on outcomes of endovascular interventionsA total of 6 blood samples (2 pre- and 4 post-intervention) will be obtained for 130 patients. PCT will be calculated from platelet volume (MPV) and platelet count, using the formula Platelet count x MPV / 10,000. The VerifyNow system tests for platelet reactivity by measuring aspirin and P2Y12 reactivity, given as Aspirin Response Units (ARU) and P2Y12 Response Units (PRU) respectively. We will perform Pearson Correlation test to determine if there is a correlation between PCT, PRU, and ARU values. Receiver Operating Characteristic (ROC) Curve Analysis will be used to determine optimal PCT cut off values to identify high platelet reactivity. Patients will be followed routinely and follow up data will be used to calculate patency, limb salvage, major adverse cardiac events, and survival rates using life table analysis, and the impact of PR on these outcomes will be studied. The true prevalence of PR in PAD patients remains unknown. This study also aims to determine the prevalence and incidence of PR in our patient population, and this information will be used to design future studies. Our hypotheses are that there is high prevalence of platelet reactivity in PAD patients and that high PCT is a marker of high PR, which is associated with decreased patency and limb salvage rates as well as increased cardiovascular morbidity and mortality.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Adults ages 18+
Have undergone extremity endovascular intervention (EVI) treatment of lower extremity peripheral arterial disease (PAD) or critical limb ischemia
On aspirin at time of the intervention and will receive dual antiplatelet therapy after surgery with aspirin and clopidogrel for at least 30 days.
Age Group: Adults
Principal Investigator: SIKANDAR KHAN
Contact(s)
SIKANDAR KHAN
sikandar@buffalo.edu
Want to Learn More?
Enrollment Update

Due to COVID-19, new enrollment in research studies will be greatly limited. If you are interested in a study, there may be a longer waiting period to receive a response to your inquiry. View the guidance for research participants for additional information.

Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.