SPECT/CT Imaging of Skeletal Muscle Perfusion

NCT02791204 | Completed

• 1 other identifier: 1603017342
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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.

  patients will be assessed prior to the revascularization procedure (baseline) and a second time 1-3 days following revascularization.

• 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.

  baseline

Study Arms (2)

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

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

Interventions

SPECT/CT imaging following revascularization procedures DEVICE

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.

Participants with PAD

SPECT/CT imaging DEVICE

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.

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* healthy control subjects will be enrolled for this study. * PAD patients with diabetes who are undergoing revascularization procedures * patients undergoing clinically indicated myocardial perfusion imaging study

You may qualify if:

• At least 18 years of age
• Normal (0.9-1.2) Ankle Brachial Index
• \) At least 18 years of age 2) scheduled for stress myocardial perfusion imaging study for clinically indicated reason
• At least 18 years of age
• 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
• 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.
• scheduled for revascularization due to obstructive blood flow in the lower extremities.

You may not qualify if:

• Unable to give informed consent
• Enrolled in another trial
• Preexisting medical conditions affecting the vascular system including, but not limited to: Coronary Artery Disease, Peripheral Arterial Disease, diabetes, cancer, hypertension, history of smoking
• Pregnant or nursing
• Unable to give informed consent or follow-up
• Enrolled in another trial
• \) Unable to give informed consent

Sponsors & Collaborators

• Yale University: lead
• University of Illinois at Urbana-Champaign: collaborator

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Albert J. Sinusas, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 6, 2016
• Study Start: May 1, 2016
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (1)