Measuring blood flow in legs using advanced imaging techniques

Quantitative Perfusion Imaging of the Lower Limb in Peripheral Arterial Disease Using Contrast Enhanced Perfusion Ultrasound, Arterial Spin Labelling Magnetic Resonance Imaging and Perfusion Angiography

This study is testing two new imaging methods to see how well blood flows in the legs and feet of people with and without Peripheral Arterial Disease.

Quick facts

• Study type: Observational
• Enrollment: 36 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University College, London (other)
• Locations: 1 site (London)
• Trial ID: NCT06103708 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate two innovative imaging techniques—contrast enhanced ultrasound perfusion and Magnetic Resonance Imaging (MRI) perfusion—to assess blood circulation in the legs and feet of individuals with and without Peripheral Arterial Disease (PAD). Participants will undergo additional scans to gather data on tissue perfusion, which is crucial for early diagnosis of PAD. The study is designed in consultation with experts in the field to ensure robust methodology and accurate results. By comparing the perfusion data from both imaging techniques, the research seeks to establish a standardized benchmark for tissue perfusion in lower limb assessments.

Who should consider this trial

Good fit: Ideal candidates include adults over 40 years old, both healthy individuals and those diagnosed with Peripheral Arterial Disease.

Not a fit: Patients with a prior history of Peripheral Arterial Disease or those with contraindications to MRI or ultrasound contrast agents may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of Peripheral Arterial Disease, potentially improving patient outcomes.

How similar studies have performed: While there is limited data on perfusion imaging in lower limbs, similar approaches in other organs have shown promising results, indicating potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

Disease-free participants:

1. Adult patients older than 40 years old
2. Subjects able to and willing to give informed consent
3. Staff from University College London Hospital/University College London

Participants with Peripheral Arterial Disease :

1. Patients able to and willing to give informed consent
2. Peripheral Arterial Disease Rutherford Classification stages 1- 6
3. Patients referred by University College London Hospital or Royal Free Hospital.

Exclusion Criteria

Disease-free participants:

1. Prior history of Peripheral Arterial Disease
2. History of diabetes, tobacco smoking or cardiovascular, vasculitides or muscle disease
3. Any contraindication to magnetic resonance imaging or contrast enhanced ultrasound- metal implants not compatible with magnetic resonance imaging; documented allergy to SonoVue; patients with right-to-left shunts assessed with transthoracic echocardiogram, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome and recent myocardial infarction/ acute coronary syndrome in the preceding 7 days.
4. Participants not from University College London Hospital/University College London

Peripheral Arterial Disease participants:

1. Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months of study enrolment
2. Any contraindication to magnetic resonance imaging or contrast enhanced ultrasound - metal implants not compatible with magnetic resonance imaging; documented allergy to SonoVue; patients with right-to-left shunts assessed with transthoracic echocardiogram, severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome and recent myocardial infarction/ acute coronary syndrome in the preceding 7 days.
3. Patients outside University College London Hospital or Royal Free Hospital.

Where this trial is running

London

• University College London Hospital — London, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Conrad von Stempel

Conditions: Vascular Diseases