Ultrasonic Perfusion Estimation in Calf Muscle

NCT04755335 | Completed FDA Device

• 3 other identifiers: 19-002559R01HL1486645R01HL148664-02
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Blood flow; Blood Vessel; Ischemia; Calf muscle pain; Vascular; Ultrasound; Intermitant claudication; Cramp

Outcome Measures

Primary Outcomes (1)

• 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

  Perfusion density of the cuff muscle will be quantified by the new automatic ultrasound microvessel quantification technique and the resulting measurements will measure the outcome of this part of the study.

  4 yeas

Secondary Outcomes (1)

• 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.

  5 years

Study Arms (2)

Early detection of PAD, assessment of the disease progression and treatment response

The objective of this arm of the study is to evaluate the potentials of Ultrasound Perfusion imaging technique for early detection of peripheral arterial disease in patients and assess the disease progression and monitor the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative perfusion estimation of calf muscle that would separate PAD from non-PAD and help early detection of PAD and would help monitoring the disease progression and treatment response.

Diagnostic Test: Ultrasound

Healthy volunteers

A group of healthy volunteers ages 18 and above with no history of smoking, cardiovascular, diabetes or surgery on legs.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

In this project, The investigators will use Alpinion ECUBE-12R (Alpinion, Bothell, WA) US platform. This state-of-the-art research US machine provides beam formed as well as Plane-Wave imaging options that allow high frame rate imaging. The investigators have characterized the acoustic output of this system for safe human studies and obtained the IRB approval for human studies. It should be noted that our technique is not limited to the Alpinion system; the investigators can also use other US systems, such as Verasonics, Vantage, (Redmond, WA). This technique can be adapted to other modern US machines in the future.

Early detection of PAD, assessment of the disease progression and treatment response; Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Ischemia; Muscle Cramp

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Azra Alizad, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 16, 2021
• Study Start: February 28, 2020
• Primary Completion: February 15, 2023
• Study Completion: May 29, 2023
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)