SPECT/CT Imaging of Skeletal Muscle Perfusion in Healthy Control Subjects and Patients PAD

Trial Purpose and Description

We hypothesize that SPECT/CT imaging of the lower extremities will provide a sensitive non-invasive imaging tool for assessing regional abnormalities in skeletal muscle perfusion. The aims of this pilot clinical study are 1) to assess the repeatability of lower extremity SPECT/CT perfusion imaging in healthy control subjects, 2) establish the feasibility of dynamic SPECT/CT imaging for absolute quantification of foot tissue perfusion in healthy controls, 3) and translate dynamic SPECT/CT perfusion imaging into PAD patients with diabetes mellitus for evaluation of lower extremity revascularization procedures.

Ages: 18 years and older

Gender: Both


Eligibility Criteria

Inclusion Criteria for Healthy Control Population:

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



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



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.
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 for PAD Patient Population:
1) Unable to give informed consent or follow-up
2) Enrolled in another trial


American Heart Association

Dates: 05/05/2016 - 04/01/2019

Last Updated: 06/02/2016

Study HIC#: 1603017342

Get Involved

For more information about this study, contact:
Donna M McMahon
+1 203-785-5005
donna.mcmahon@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigator

Albert John Sinusas

Principal Investigator