Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Location status: Recruiting
NCT Number: NCT03622359
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Columbus, Ohio, 43205, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patients with Peripheral Artery Disease:
Exclusion criteria
for Patients with Peripheral Artery Disease:
Inclusion criteria
for Healthy Control Subjects:
Exclusion criteria
for Healthy Control Subjects:
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
Time frame: 1-2 weeks
The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.
Time frame: 1 year
Rates of wound healing will be documented for 12 months following enrollment into the imaging study.
Time frame: 1 year
Amputation rates will be documented for the 12 months following enrollment into the imaging study.
Contact information is provided by the study sponsor or research team.
Nationwide Children's Hospital
Other
Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease
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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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