Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
140 participants
OBSERVATIONAL
2016-05-31
2026-12-31
Brief Summary
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Detailed Description
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In this clinical study, the investigators will evaluate lower extremity skeletal muscle perfusion in the feet of healthy controls and PAD patients who are undergoing revascularization using conventional sodium iodide SPECT/CT imaging, as well as dynamic SPECT/CT imaging with a unique cadmium zinc telluride (CZT) system.
Healthy control subjects will be recruited from Yale University and the greater New Haven area. In addition to healthy control subjects, 35 PAD patients with previously diagnosed diabetes will be recruited from Vascular Surgery and Interventional Cardiology at Yale-New Haven Hospital. Patients who are undergoing revascularization procedures will be identified and asked to participate in the imaging study prior to their revascularization procedure and will be imaged once again 1-3 days following revascularization, prior to hospital discharge.
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. They will be injected with a low dose radiotracer. In healthy control subjects, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes. Additionally, we will sample heated venous "arterialized" blood from a hand vein retrograde to evaluate the potential for heated venous blood in the calculation of a blood input function, thus eliminating the need for arterial access in future PAD patient studies.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Participants with PAD
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained.
SPECT/CT imaging following revascularization procedures
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained.
Controls
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes.
SPECT/CT imaging
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes.
Interventions
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SPECT/CT imaging following revascularization procedures
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained.
SPECT/CT imaging
Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes.
Eligibility Criteria
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Inclusion Criteria
2. Normal (0.9-1.2) Ankle Brachial Index
1\) At least 18 years of age 2) scheduled for stress myocardial perfusion imaging study for clinically indicated reason
1. At least 18 years of age
2. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by CT angiography, ultrasound, or MR imaging or an abnormal ankle-brachial index or toe-brachial index
3. Previously diagnosed diabetes mellitus (type I or II), based on any of the following criteria: fasting plasma glucose great than 126 mg/dl on 2 separate occasions, glycated hemoglobin (HbA1c) greater than 6.5% on 2 separate occasions, fasting plasma glucose greater than 200 mg/dl 2 hours following an oral glucose tolerance test on 2 separate occasions, or fasting plasma glucose and HbA1c above normal limits on same visit.
4. scheduled for revascularization due to obstructive blood flow in the lower extremities.
Exclusion Criteria
2. Enrolled in another trial
3. Preexisting medical conditions affecting the vascular system including, but not limited to: Coronary Artery Disease, Peripheral Arterial Disease, diabetes, cancer, hypertension, history of smoking
4. Pregnant or nursing
1. Unable to give informed consent or follow-up
2. Enrolled in another trial
1\) Unable to give informed consent
18 Years
ALL
Yes
Sponsors
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University of Illinois at Urbana-Champaign
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Albert J. Sinusas, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale-New Haven Hospital
New Haven, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1603017342
Identifier Type: -
Identifier Source: org_study_id
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