Imaging blood flow in patients with peripheral artery disease
Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease
This study is testing how imaging blood flow in the legs can help doctors understand and improve treatment for people with peripheral artery disease who are having surgery to restore blood flow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT03622359 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with significant obstructive disease in lower extremity arteries.
Not a fit: Patients who are unable to provide informed consent, pregnant, or under 18 years of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict clinical outcomes and improve treatment strategies for patients with peripheral artery disease.
How similar studies have performed: Other studies utilizing similar imaging techniques have shown promise in assessing vascular conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.