Clinical trial NCT04755335: Ultrasonic Perfusion Estimation in Calf Muscle
Official title: Ultrasonic Perfusion Imaging of Peripheral Vascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: Blood flow
Blood Vessel
Ischemia
Calf muscle pain
Vascular
Ultrasound
Intermitant claudication
Cramp
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-02-16
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject population will include n=300 symptomatic patients with claudication, at risk for PAD (150 abnormal ABI and 100 with normal ABI), male and female, age ≥18 years and are referred Mayo Clinic Vascular Center due to claudication or atypical leg symptoms for ABI examination. In addition to comparing to the group of Normal (symptomatic patients with normal resting and exercise ABI), the study will also include 50 healthy volunteers with normal ABI and with no history of smoking cardiovascular and metabolic disorders, including diabetes mellitus.

Brief summary: The purpose of this study is to evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (PAD) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations.

Detailed description: The clinical manifestations of peripheral arterial disease (PAD), regardless of etiology, are due to a lack of blood flow to the musculature relative to its metabolism, which results in pain in the affected muscle groups. PAD affecting the lower extremities causes claudication, cramping pain in the calf muscle, thigh or hip muscle induced by exercise. The initial test for evaluation of patients with claudication is ankle brachial index (ABI).

Therefore, a non-invasive and affordable US technique that can quantify blood perfusion and microvasculature density, without using contrast agent, will improve PAD detection in early stage and can monitor the disease progress as well as the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative imaging of perfusion that would help separating PAD from non-PAD and monitor the disease progression and treatment response.

Eligibility criteria: Inclusion Criteria:

* Male and female volunteers \> 18 years old.
* Male and female volunteers with symptom of claudication and suspected peripheral arterial disease (PAD) who are scheduled for vascular testing.

Exclusion Criteria:

* Patients with gangrene.
* Patients with lower leg amputation.
* Having ulcer and any health condition that does not allow proper use of ultrasound scanning.
* People considered in "vulnerable" populations.

Primary outcomes:
measure: Aim 1: Determine the efficacy of ultrasonic perfusion imaging for early detection of PAD. The goal is to quantify the perfusion of cuff muscle in patients with lower leg claudication and compare the results to those obtained in healthy individuals
timeFrame: 4 yeas
Secondary outcomes:
measure: Aim 2: Determine the efficacy of ultrasonic perfusion imaging for assessment of treatment response in PAD patients. The goal is to quantify the perfusion of the cuff muscle in PAD patients in 3 time points, 6 months, and every year after treatment.
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Azra Alizad, MD
role: PRINCIPAL_INVESTIGATOR
References: