Super-resolution ultrasound imaging for peripheral artery disease

The Predictive Value of Super-resolution Ultrasound Microvascular Imaging for the Prognosis of Peripheral Artery Disease

This project will test whether super-resolution contrast ultrasound can reveal small-vessel problems in adults with or without peripheral artery disease.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07374601 on ClinicalTrials.gov

What this trial studies

This observational, single-center study uses super-resolution contrast-enhanced ultrasound to image the muscle and skin microvasculature in adults with clinically confirmed peripheral artery disease and in healthy control volunteers. Participants undergo ankle-brachial index screening and vascular imaging to confirm group assignment, then receive contrast-enhanced ultrasound with microbubble tracking to visualize arterioles and capillaries ≤100 micrometers. Investigators will compare microvascular structure and perfusion measures between PAD patients and controls to characterize microvascular dysfunction. The study is conducted at Peking University First Hospital in Beijing and does not alter participants' medical treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–100 with confirmed peripheral artery disease or healthy adults without PAD who can consent and undergo contrast-enhanced ultrasound.

Not a fit: People who cannot undergo contrast-enhanced ultrasound (for example due to contrast allergy), who have severe involuntary movement disorders that prevent reliable imaging, or who cannot travel to the study site are unlikely to benefit.

Why it matters

Potential benefit: If successful, this imaging approach could help detect microvascular dysfunction earlier and guide more personalized care for people with peripheral artery disease.

How similar studies have performed: Early research and pilot studies of super-resolution and contrast-enhanced ultrasound have shown promise for visualizing microvascular networks, but applying SRUMI specifically to PAD is relatively novel.

Eligibility criteria

\*Inclusion Criteria:\*

1. Adults aged ≥18 years and ≤100 years;
2. Diagnosis of peripheral artery disease (PAD) confirmed by comprehensive clinical assessment-including characteristic symptoms (e.g., intermittent claudication, rest pain), physical findings (e.g., diminished or absent distal pulses, bruits), ankle-brachial index (ABI) \< 0.9, and corroborating vascular imaging (e.g., duplex ultrasonography, CTA, or MRA);
3. Alternatively, healthy adults without PAD (i.e., ABI ≥ 0.9, absence of suggestive symptoms or signs, and no history of atherosclerotic cardiovascular disease) who meet all other eligibility requirements;
4. Willing and able to provide written informed consent.

\*Exclusion Criteria:\*

1. Inability to complete study procedures due to:

   1. Severe involuntary movement disorders (e.g., advanced Parkinson's disease or cerebellar ataxia) interfering with image acquisition;
   2. Contraindication to contrast-enhanced ultrasound (e.g., documented hypersensitivity to sulfur hexafluoride microbubble contrast agent \[SonoVue®\]);
   3. Active lower-limb infection (e.g., diabetic foot infection with systemic signs or osteomyelitis), which precludes safe or interpretable data collection;
2. Cognitive impairment or legal incapacity precluding autonomous informed consent;
3. Refusal-by the participant or their legally authorized representative-to provide informed consent.

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Min Yang, M.D.

Conditions Peripheral Artery Disease