Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

  • STATUS
    Recruiting
  • days left to enroll
    25
  • participants needed
    200
  • sponsor
    Nationwide Children's Hospital
Updated on 12 February 2022
arteriopathy
angiography
computed tomography angiography
vascular disease
revascularisation
obstructive disease

Summary

The aim of this clinical study is to assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in diabetic patients with peripheral arterial 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 assessing regional abnormalities in foot/calf muscle perfusion and evaluating treatment responses.

Description

PAD patients (n=200) with peripheral arterial 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.

Details
Condition Peripheral Arterial Disease, Diabetes Mellitus, Critical Limb Ischemia
Treatment SPECT/CT perfusion imaging, SPECT/CT or PET/CT perfusion imaging, PET/CT perfusion imaging
Clinical Study IdentifierNCT03622359
SponsorNationwide Children's Hospital
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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