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NCT Number: NCT03622359

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

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.

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Key information

About this study

PAD patients (n=80) with peripheral artery disease (PAD) who are scheduled to undergo lower extremity revascularization procedures will be recruited. Patients will be screened using a standard medical history questionnaire and a physical activity questionnaire. Once their questionnaires are reviewed, individuals who meet inclusion criteria will proceed with standard PAD screening, which will include Ankle-Brachial Indices (ABIs) and Toe-Brachial Indices (TBIs) of both lower extremities. Patients will undergo SPECT/CT or PET/CT perfusion imaging prior to their revascularization procedure and 1-14 days following revascularization. Subjects will receive an intravenous injection of a standard clinical dose of radiotracer for both imaging sessions. A low-dose CT scan will be performed immediately after each SPECT and PET image acquisition for the purposes of attenuation correction and regional analysis of radiotracer uptake. Clinical outcomes will be evaluated for up to 12 months after the imaging study to assess the prognostic value of perfusion imaging for predicting subsequent outcomes. An additional subset of PAD patients (n=56) and healthy control subjects (n=56) will be enrolled to undergo the same imaging procedures to establish a healthy database for PET perfusion imaging measures.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Patients with Peripheral Artery Disease:

  • 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.

Exclusion criteria

for Patients with Peripheral Artery Disease:

  • Unable to give informed consent or follow-up
  • Pregnant or nursing
  • Under the age of 18
  • No history of peripheral artery disease

Inclusion criteria

for Healthy Control Subjects:

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

Exclusion criteria

for Healthy Control Subjects:

  • Unable to give informed consent of follow-up
  • Pregnant or nursing
  • Under the age of 18
  • History of peripheral artery disease

Treatment and study plan

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.

Primary outcomes

  1. Lower extremity perfusion

    Time frame: 1-2 weeks

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

Secondary outcomes

  1. Wound healing

    Time frame: 1 year

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

  2. Limb salvage

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mitchel R Stacy, Ph.D.

CONTACT

[email protected]

614-355-5836

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Collaborators

  • Ohio State University

Registry information

Official study title

Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Aug 9, 2018
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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