Using Near-Infrared Light to Better Understand Peripheral Artery Disease

Официальное название

Near-Infrared Diffuse Correlation Spectroscopy to Better Define the Pathophysiology of Peripheral Artery Disease

Обзор

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.

Подробное описание

Subjects that do not have peripheral artery disease will complete the study procedures up to two times (baseline and follow-up at 1-2 months).

Subjects diagnosed with peripheral artery disease may be asked to complete the study procedures up to 4 separate times (baseline, follow-up at 1-2 weeks, 1-2 months, and 4-6 months). The investigators will work with them to schedule each visit.

All participants will provide informed consent prior to participating in the study. The screening procedures will include collecting information about health history, age, sex, race/ethnicity, height, weight, and reasons one should not undergo an MRI or exercise.

The laboratory procedures will include questionnaires about quality of life and walking ability, Ankle- Brachial Index, functional performance measures (treadmill walking and six minute walk distance), wearable activity monitor and activity log, and lower limb MRI with muscle perfusion and oxygenation measures at rest and in response to physiologic provocation (ischemia-reperfusion and exercise).

Investigators may ask subjects to return on a separate day to repeat part, or all, of the study procedures depending on image quality and/or equipment performance.

Первичные конечные точки

• Perceived Quality of life [Срок оценки: Baseline and up to 26 weeks]
• Ankle- Brachial Index [Срок оценки: Baseline and upto 26 weeks]
• Walking ability [Срок оценки: Baseline and upto 26 weeks]
• Functional performance [Срок оценки: Baseline and upto 26 weeks]
• Steps taken [Срок оценки: Baseline and upto 26 weeks]
• Oxygen level of leg muscles [Срок оценки: Baseline and upto 26 weeks]
• Body composition [Срок оценки: Baseline and up to 26 weeks]
• Leg Exercise MRI [Срок оценки: Baseline and upto 26 weeks]
• Lower Leg Ischemia-Reperfusion [Срок оценки: Baseline and up to 26 weeks]
• Leg muscle size and quality [Срок оценки: Baseline and up to 26 weeks]

Критерии участия

Критерии включения

• Cases, Aim 1

• 18 or older
• willing to participate under the conditions described in the informed consent form (ICF)
• eligible to sign the ICF
• established diagnosis of PAD confirmed by a physician
• 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

Критерии исключения

• Cases, Aim 1

• Ankle-Brachial Index >0.9 or <0.4
• isolated disease in aorta/iliac vessels
• unstable angina or myocardial infarction in past 12 months
• orthopedic or other physical limitations which would prevent data collection
• 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

• unstable angina or myocardial infarction in past 12 months
• orthopedic or other physical limitations which would prevent data collection
• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 2 центра

• University of Texas at Arlington — Arlington
• University of Texas Arlington — Arlington

Идентификаторы

NCT: NCT07313410 · 2025-0414 · 25CSA1432263

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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