Quantitative Perfusion Imaging Using Contrast Enhanced Perfusion Ultrasound, MRI and Perfusion An… (NCT06103708) | Clinical Trial Compass
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Quantitative Perfusion Imaging Using Contrast Enhanced Perfusion Ultrasound, MRI and Perfusion Angiography
United Kingdom36 participantsStarted 2023-09-11
Plain-language 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
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Patients able to and willing to give informed consent
. Patients referred by University College London Hospital or Royal Free Hospital.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A novel quantitative imaging biomarker of tissue perfusion
. 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
. 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.