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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2017-02-17 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Mitchel R Stacy, Ph.D.
PRINCIPAL INVESTIGATOR
Nationwide Children's Hospital
Frequently Asked Questions
Who can join the NCT03622359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03622359 currently recruiting?
Yes, NCT03622359 is actively recruiting participants. Contact the research team at Mitchel.Stacy@nationwidechildrens.org for enrollment information.
Where is the NCT03622359 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT03622359 clinical trial?
NCT03622359 is sponsored by Nationwide Children's Hospital. The principal investigator is Mitchel R Stacy, Ph.D. at Nationwide Children's Hospital. The trial plans to enroll 192 participants.