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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ At least 18 years of age

⁃ Normal (0.9-1.2) Ankle Brachial Index

‣ 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:

⁃ 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.

Locations
United States
Connecticut
Yale-New Haven Hospital
RECRUITING
New Haven
Contact Information
Primary
Albert J. Sinusas, MD
albert.sinusas@yale.edu
203-785-5005
Backup
Donna McMahon
donna.mcmahon@yale.edu
203-785-5005
Time Frame
Start Date: 2016-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 140
Treatments
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.
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.
Sponsors
Collaborators: University of Illinois at Urbana-Champaign
Leads: Yale University

This content was sourced from clinicaltrials.gov