Point of care screening for HPR for Peripheral Arterial Disease (PAD)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Pittsburgh Medical Center, Pittsburgh, PA
Peripheral Arterial Disease (PAD)+8 More
Point of care screening for HPR - DiagnosticTest
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether screening for and intervening on patients with high on treatment platelet reactivity undergoing lower extremity arterial endovascular interventions is beneficial.

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Eligible Conditions

  • Peripheral Arterial Disease (PAD)
  • CLOPIDOGREL, POOR METABOLISM of (Disorder)
  • Peripheral Arterial Occlusive Disease (PAOD)
  • Artery Disease
  • Peripheral Vascular Disease Patient

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Peripheral Arterial Disease (PAD)

Study Objectives

This trial is evaluating whether Point of care screening for HPR will improve 1 primary outcome and 3 secondary outcomes in patients with Peripheral Arterial Disease (PAD). Measurement will happen over the course of after study completion.

after study completion
Correlation of HPR testing results
one year from intervention
Major adverse cardiovascular events
Proportion of participants with primary patency
proportion of participants with amputation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Peripheral Arterial Disease (PAD)

Trial Design

2 Treatment Groups

Control: guideline based therapy
1 of 2
Experimental: screening/treating for HPR
1 of 2
Active Control
Experimental Treatment

This trial requires 296 total participants across 2 different treatment groups

This trial involves 2 different treatments. Point Of Care Screening For HPR is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental: screening/treating for HPRParticipants randomized to this arm will be screened and treated for HPR. Pharmacogenetics testing for CYP2C19 polymorphisms will be collected, stored, and analyzed at study completion.
Control: guideline based therapyParticipants randomized to this arm will receive usual care without screening for HPR. Pharmacogenetics testing for CYP2C19 polymorphisms will be collected, stored, and analyzed at study completion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ticagrelor
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year from intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly one year from intervention for reporting.

Closest Location

University of Pittsburgh Medical Center - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Peripheral arterial disease
Planned angioplasty or stenting of superficial femoral artery or popliteal artery.

Patient Q&A Section

What causes peripheral arterial disease?

"Although a clear cause is not universally recognised it seems clear that many common vascular risk factors are linked to an increased incidence and prevalence of peripheral arterial disease. The increased incidence of peripheral arterial disease seen in men with prior myocardial infarction is especially intriguing and the extent to which increased cardiovascular risk is due to shared genetic susceptibility or environmental influences needs to be determined." - Anonymous Online Contributor

Unverified Answer

What is peripheral arterial disease?

"Peripheral arterial disease is a disorder of the small arteries and arterioles that are located above the knee in the limb. It is often a result of the buildup of plaque in the arteries that make up the lower extremities. There may also be a buildup of plaque in the arteries in the leg above the knee. Patients usually begin to feel symptoms of peripheral arterial disease as their legs becomes clogged.\n" - Anonymous Online Contributor

Unverified Answer

How many people get peripheral arterial disease a year in the United States?

"About 7.9 million Americans are diagnosed with arterial disease of the lower limbs each year, and the risk of death among these patients is about 11 times greater than the general population." - Anonymous Online Contributor

Unverified Answer

Can peripheral arterial disease be cured?

"In symptomatic peripheral arterial disease, the treatment should be done according to existing evidence and experience, and to maximize the quality of life. The treatment of PAD is likely to have less effect on the survival of PAD patients than on delaying disease progression but improving quality of life." - Anonymous Online Contributor

Unverified Answer

What are the signs of peripheral arterial disease?

"Signs of peripheral arterial disease include increased ankle to brachial ratio on pulse examination, bruit at the ankle during arterial phase of duplex ultrasound scanning." - Anonymous Online Contributor

Unverified Answer

What are common treatments for peripheral arterial disease?

"Most common treatment for claudication by primary healthcare providers is referral for PTA. More importantly, the common treatment for PAD is exercise, which may actually cause a change in the way claudication is viewed and treated by primary healthcare providers. Physicians should keep their treatments up-to-date and emphasize the role of exercise in treatment." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating peripheral arterial disease?

"Today, new treatment options for PAD are limited in terms of their efficacy and feasibility. However, there have been recent advances made in developing new therapies for the treatment of PAD and vascular disease in general. Research is still ongoing to further improve PAD-specific treatment options." - Anonymous Online Contributor

Unverified Answer

What is point of care screening for hpr?

"Screening for hereditary hemorrhagic conditions is commonly performed in health systems with limited resources at points of care where there are no definitive diagnostic tests such as specialized laboratories. The performance of validated point-of-care tests such as HPB in an emergency setting as shown in this study can be highly effective in identifying individuals who require further diagnostic evaluation with testing that is not readily available." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of peripheral arterial disease?

"Data from a recent study, PAD was more common in white patients, had a history of smoking, and was more frequent in patients with diabetes without other risk factors for atherosclerosis, such as hypertension or hypercholesterolemia. No significant differences were observed for sex, age, family history of PAD, type of diabetes, level of microvascular surveillance, atherosclerotic risk factors, or prior cardiovascular surgery. The cause of PAD was found to be a combination of identifiable atherosclerotic risk factors, known aetiologies, and other undetermined causes." - Anonymous Online Contributor

Unverified Answer

How does point of care screening for hpr work?

"The use of the HPS in the clinic setting will decrease the number of CXRs performed and the radiation exposure received by patients. The decrease in CXRs performed will be clinically beneficial for patients and overall, the facility." - Anonymous Online Contributor

Unverified Answer

Does peripheral arterial disease run in families?

"In a recent study, findings we used a rigorous control sample and were able to control for important lifestyle and family characteristics that may influence PAD prevalence. There is no evidence in this study linking familial PAD with disease penetrance or with specific genetic risk variants." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of point of care screening for hpr?

"Among patients in need of POC testing on the grounds of PAD, the majority were tested, but several common side effects were observed. Patients' perceptions of test result disclosure, satisfaction with POC test performance and the overall experience of POC test utilization may be important considerations in clinical decision-making." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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