NCT03622359 Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
| NCT ID | NCT03622359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nationwide Children's Hospital |
| Condition | Peripheral Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2017-02-17 |
| Primary Completion | 2028-08-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.
Eligibility 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