Ultrasonic Perfusion Estimation in Calf Muscle

NCT ID: NCT04755335

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2023-05-29

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ultrasound

Intervention Type: 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.

Healthy volunteers

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

Ultrasound

Intervention Type: 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.

Interventions

Ultrasound

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Azra Alizad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azra Alizad, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HL148664

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01HL148664-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-002559

Identifier Type: -

Identifier Source: org_study_id