Imaging blood flow in patients with peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to create a healthy database for nuclear perfusion imaging of the lower extremities and evaluate the prognostic value of radiotracer-based perfusion imaging in patients with peripheral artery disease (PAD) undergoing lower extremity revascularization. A total of 80 PAD patients will be recruited to undergo SPECT/CT or PET/CT imaging before and after their revascularization procedures. The study will assess regional abnormalities in muscle perfusion and monitor clinical outcomes for up to 12 months post-imaging. An additional 56 healthy control subjects will also participate to establish a baseline for comparison.

Why it matters

Who can join: the full rules

Inclusion Criteria for Patients with Peripheral Artery Disease:

1. At least 18 years of age
2. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging.

Exclusion Criteria for Patients with Peripheral Artery Disease:

1. Unable to give informed consent or follow-up
2. Pregnant or nursing
3. Under the age of 18
4. No history of peripheral artery disease

Inclusion Criteria for Healthy Control Subjects:

1. At least 18 years of age
2. No evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening.

Exclusion Criteria for Healthy Control Subjects:

1. Unable to give informed consent of follow-up
2. Pregnant or nursing
3. Under the age of 18
4. History of peripheral artery disease

Where it's running

• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Mitchel R Stacy, Ph.D. — Nationwide Children's Hospital
• Study coordinator: Mitchel R Stacy, Ph.D.
• Email: Mitchel.Stacy@nationwidechildrens.org
• Phone: 614-355-5836

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.