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SPECT/CT Imaging of Skeletal Muscle Perfusion

RECRUITINGSponsored by Yale University
Actively Recruiting
SponsorYale University
Started2016-05
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

DiabetesDiabetes MellitusPeripheral Arterial Disease

Locations1 site

Yale-New Haven Hospital
New Haven, Connecticut, 06510
Albert J Sinusas, MD203-785-5005albert.sinusas@yale.edu

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