Health TrialsbyHealthPanel

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

ConditionsPeripheral Artery DiseaseDiabetes MellitusChronic Limb-Threatening Ischemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNationwide Children's Hospital

About this trial

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

This trial accepts healthy volunteers

Qualifiers

At least 18 years of age

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

Disqualifiers

Unable to give informed consent or follow-up

Pregnant or nursing

Under the age of 18

No history of peripheral artery disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPECT/CT perfusion imaging

    Diagnostic test

    Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.

  • PET/CT perfusion imaging

    Diagnostic test

    Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: SPECT/CT perfusion imagingExperimental treatment 2 interventions
Group B: PET/CT perfusion imagingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Lower extremity perfusion

The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.

Time frame
1-2 weeks

Secondary outcomes

1

Wound healing

Rates of wound healing will be documented for 12 months following enrollment into the imaging study.

Time frame
1 year
2

Limb salvage

Amputation rates will be documented for the 12 months following enrollment into the imaging study.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nationwide Children's Hospital

Lead sponsor

Ohio State University

Collaborator

Source ClinicalTrials.gov
Apply now