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SPECT/CT Imaging of Skeletal Muscle Perfusion

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ClinicalTrials.gov Identifier: NCT02791204
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
This study will use SPECT/CT imaging to assess the effect of percutaneous revascularization treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the disease can progress more quickly than in patients without diabetes.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Diabetes Mellitus Device: SPECT/CT imaging following revascularization procedures Device: SPECT/CT imaging Not Applicable

Detailed Description:

Peripheral arterial disease (PAD) is a progressive atherosclerotic disease of the lower limbs that affects 8 to 10 million Americans, and is more prevalent and progresses more quickly in patients with diabetes mellitus (DM). There is a critical need for a standard non-invasive approach to assess response to treatment by three-dimensional (3D) perfusion to vascular territories of the feet in PAD patients. Assessing the response to treatment is particularly important in DM patients, who suffer from poor distal runoff and often require more distal revascularization to achieve limb salvage.

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 (n=15) 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SPECT/CT Imaging of Skeletal Muscle Perfusion in Healthy Control Subjects and Patients With Peripheral Arterial Disease: Pilot Clinical Study
Actual Study Start Date : May 2016
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.
Active Comparator: 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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of effect of percutaneous revascularization treatment measured by change in lower extremity skeletal muscle perfusion before and after treatment using quantitative SPECT/CT imaging of the lower extremities. [ Time Frame: patients will be assessed prior to the revascularization procedure (baseline) and a second time 1-3 days following revascularization. ]
  2. Assessment of lower extremity skeletal muscle perfusion in healthy control subjects compared to patients with peripheral arterial disease and diabetes using quantitative SPECT/CT imaging. [ Time Frame: baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • CONTROLS

    1. At least 18 years of age
    2. Normal (0.9-1.2) Ankle Brachial Index

  • PAD PATIENTS

    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.
    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.

Exclusion Criteria:

  • CONTROLS

    1. Unable to give informed consent
    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

  • PAD PATIENTS

    1. Unable to give informed consent or follow-up
    2. Enrolled in another trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791204


Contacts
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Contact: Albert J. Sinusas, MD 203-785-5005 albert.sinusas@yale.edu
Contact: Donna McMahon 203-785-5005 donna.mcmahon@yale.edu

Locations
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United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Albert J Sinusas, MD    203-785-5005    albert.sinusas@yale.edu   
Contact: Donna McMahon       donna.mcmahon@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Albert J. Sinusas, MD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02791204    
Other Study ID Numbers: 1603017342
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases