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Perfusion Imaging for Peripheral Arterial Disease

N/A

Recruiting

Led By Mitchel R Stacy, Ph.D.

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging.

At least 18 years of age

Must not have

Under the age of 18

No history of peripheral arterial disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether radiotracer-based perfusion imaging can help predict clinical outcomes for diabetic patients with PAD undergoing lower extremity revascularization procedures.

Who is the study for?

This trial is for adults over 18 with peripheral arterial disease (PAD), specifically diabetic patients needing lower extremity revascularization. They must have evidence of significant artery blockage in the legs, confirmed by previous medical imaging tests.

What is being tested?

The study is testing two types of perfusion imaging: SPECT/CT and PET/CT to see how well they predict outcomes after leg blood flow restoration procedures in PAD patients. It aims to evaluate if these scans can effectively assess muscle blood supply issues and monitor treatment success.

What are the potential side effects?

Since this trial involves diagnostic imaging, potential side effects may include allergic reactions to contrast agents used during scans, radiation exposure risks, and discomfort or bruising from IV line placement for radiotracers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with blocked arteries in my legs.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have never had peripheral arterial disease.

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I am unable to understand or follow the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lower extremity perfusion

Secondary study objectives

Limb salvage

Wound healing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: SPECT/CT perfusion imagingExperimental Treatment2 Interventions

Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo SPECT/CT imaging as part of the research protocol.

Group II: PET/CT perfusion imagingExperimental Treatment2 Interventions

Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo PET/CT imaging as part of the research protocol.

0 / 5Eligibility criteria met