Imaging skeletal muscle blood flow in patients with Peripheral Arterial Disease and diabetes

SPECT/CT Imaging of Skeletal Muscle Perfusion in Healthy Control Subjects and Patients With Peripheral Arterial Disease: Pilot Clinical Study

This study is testing how well a new imaging method can show blood flow in the feet of people with Peripheral Arterial Disease and diabetes before and after they receive a specific treatment to improve blood flow.

Quick facts

• Study type: Observational
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT02791204 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effects of percutaneous revascularization treatments on skeletal muscle perfusion in patients with Peripheral Arterial Disease (PAD) and diabetes mellitus. Using SPECT/CT imaging, the study will assess blood flow in the feet of PAD patients before and after their revascularization procedures. Healthy controls will also be included for comparison. The goal is to establish a non-invasive method to monitor treatment responses, particularly in patients with diabetes who experience more severe disease progression.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with diagnosed Peripheral Arterial Disease and diabetes who are scheduled for revascularization procedures.

Not a fit: Patients without diabetes or those not diagnosed with Peripheral Arterial Disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new non-invasive method to assess treatment effectiveness in PAD patients with diabetes, potentially improving patient outcomes.

How similar studies have performed: While the use of SPECT/CT imaging in this specific context is novel, similar imaging techniques have shown promise in assessing vascular conditions in other studies.

Eligibility criteria

Inclusion Criteria for Healthy Control Population:

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

Inclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:

1) At least 18 years of age 2) scheduled for stress myocardial perfusion imaging study for clinically indicated reason

-Inclusion Criteria for PAD Patient Population:

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 for Healthy Control Population:

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

Exclusion Criteria for PAD Patient Population:

1. Unable to give informed consent or follow-up
2. Enrolled in another trial

Exclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:

1) Unable to give informed consent

Where this trial is running

New Haven, Connecticut

• Yale-New Haven Hospital — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Principal investigator: Albert J. Sinusas, MD — Yale University
• Study coordinator: Albert J. Sinusas, MD

Conditions Peripheral Arterial Disease; Diabetes Mellitus