Quantitative Perfusion Imaging Using Contrast Enhanced Perfusion Ultrasound, MRI and Perfusion Angiography

NCT06103708 | Recruiting

• 1 other identifier: 145177
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral Arterial Disease is the narrowing and blocking of the blood vessels that supply the legs and feet. It is a common and progressive condition that affects patients of all backgrounds and genders and is more common in people with other problems such as heart disease, high blood pressure and diabetes mellitus as well being linked to ageing. It can be a severe disease and in 20% of patients can lead to pain on walking short distances and 2% of people can lead to painful ulceration, constant pain and can lead to amputation of part or all of the affected leg. The investigators are researching 2 different types of new scanning techniques to measure the amount of blood that is circulating within the tissues of the leg and foot (known as tissue perfusion). The investigators want to measure tissue perfusion in people both with and without Peripheral Arterial Disease. This will help find a more sensitive method to diagnose Peripheral Arterial Disease earlier and help identify those with worsening arterial narrowing before they develop ulcers. Measuring tissue perfusion will guide doctors with decision about what procedure can be performed to improve blood flow in people with Peripheral Arterial Disease . Patients with all degrees of Peripheral Arterial Disease will be eligible to take part in this study. The study will take part at University College London and Royal Free Hospital. The research will run along side normal investigations and treatment for Peripheral Arterial Disease and the study period will be 2 years. Participants will undergo an ultrasound scan of the lower leg with an injection of a special dye into a vein in the arm, as well as a magnetic resonance

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• A novel quantitative imaging biomarker of tissue perfusion

  A novel quantitative imaging biomarker of tissue perfusion will be measured as a reference value to guide clinical assessment in patients with peripheral arterial disease.

  12 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants for disease-free cohort will be recruited from University College London Hospital/University College London Participants with Peripheral Arterial Disease will be recruited directly by the clinical team at University College London Hospital or Royal Free Hospital.

You may qualify if:

• Disease-free participants:
• Adult patients older than 40 years old
• Subjects able to and willing to give informed consent
• Staff from University College London Hospital/University College London
• Participants with Peripheral Arterial Disease :
• Patients able to and willing to give informed consent
• Peripheral Arterial Disease Rutherford Classification stages 1- 6
• Patients referred by University College London Hospital or Royal Free Hospital.

You may not qualify if:

• Disease-free participants:
• Prior history of Peripheral Arterial Disease
• History of diabetes, tobacco smoking or cardiovascular, vasculitides or muscle disease
• 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.
• Participants not from University College London Hospital/University College London
• Peripheral Arterial Disease participants:
• Concurrent and/or recent involvement in other research that is likely to interfere with the intervention within 3 months of study enrolment
• 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.
• Patients outside University College London Hospital or Royal Free Hospital.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Conrad von Stempel

CONTACT

02034567890; conrad.vonstempel@nhs.net

Katerina Soteriou

CONTACT

02034567890; katerina.soteriou@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 27, 2023
• Study Start: September 11, 2023
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

GB (1)