RECRUITINGOBSERVATIONAL
Using Near-Infrared Light to Better Understand Peripheral Artery Disease
Near-Infrared Diffuse Correlation Spectroscopy to Better Define the Pathophysiology of Peripheral Artery Disease
About This Trial
The goal of this study is to better understand how blood flows and how oxygen is utilized in the lower limbs of people who suffer from peripheral artery disease. This study will also assess how these factors affect treatment outcomes. Specific aims include: Aim 1: Utilize BB-NIR-DCS to differentiate PAD patients experiencing primary oxygen delivery limitations from those suffering from mitochondrial dysfunction. Aim 2: Test the efficacy of BB-NIR-DCS at predicting individual responses to vascular intervention.
Who May Be Eligible (Plain English)
Who May Qualify:
- Cases, Aim 1
1. 18 or older
2. willing to participate under the conditions described in the willing to sign a consent form form (ICF)
3. eligible to sign the ICF
4. established diagnosis of PAD confirmed by a physician
5. able to comply with the study requirements
- Cases, Aim 2
1\) completed Aim 1
- Controls 1) asymptomatic, with no history or diagnosis of peripheral artery disease
Who Should NOT Join This Trial:
- Cases, Aim 1
1. Ankle-Brachial Index \>0.9 or \<0.4
2. isolated disease in aorta/iliac vessels
3. unstable angina or myocardial infarction in past 12 months
4. orthopedic or other physical limitations which would prevent data collection
5. contraindications to MRI, including presence of a Pacemaker, presence of bone growth/ bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator
- Cases, Aim 2
1. unstable angina or myocardial infarction in past 12 months
2. orthopedic or other physical limitations which would prevent data collection
3. contraindications to MRI, including presence of a pacemaker, presence of bone growth/ bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator).
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Cases, Aim 1
1. 18 or older
2. willing to participate under the conditions described in the informed consent form (ICF)
3. eligible to sign the ICF
4. established diagnosis of PAD confirmed by a physician
5. able to comply with the study requirements
* Cases, Aim 2
1\) completed Aim 1
* Controls 1) asymptomatic, with no history or diagnosis of peripheral artery disease
Exclusion Criteria:
* Cases, Aim 1
1. Ankle-Brachial Index \>0.9 or \<0.4
2. isolated disease in aorta/iliac vessels
3. unstable angina or myocardial infarction in past 12 months
4. orthopedic or other physical limitations which would prevent data collection
5. contraindications to MRI, including presence of a Pacemaker, presence of bone growth/ bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator
* Cases, Aim 2
1. unstable angina or myocardial infarction in past 12 months
2. orthopedic or other physical limitations which would prevent data collection
3. contraindications to MRI, including presence of a pacemaker, presence of bone growth/ bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator).
* Controls 1) history of peripheral artery disease 2) overt cardiovascular disease (e.g. heart failure) 3) known pulmonary disease (excluding mild asthma) 4) current tobacco use 5) orthopedic or other physical limitations which would prevent data collection, 6) BP \>150/90 mmHg at screening 7) contraindications to MRI, including presence of a pacemaker, presence of bone growth/ bone fusion stimulators, presence of tissue expander, presence of cochlear implants, unable to ambulate for 10 feet, receiving continuous Oxygen therapy, pregnancy, permanent Jewelry (screened using MRI safety screening form and verbal screening by MRI operator).
Locations (2)
University of Texas at Arlington
Arlington, Texas, United States
University of Texas Arlington
Arlington, Texas, United States