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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- A novel quantitative imaging biomarker of tissue perfusion
研究概览
简要总结
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
详细描述
Participants in this study will either be a group of healthy disease-free participants or participants with peripheral arterial disease.
In the Peripheral Arterial Disease group, participants care will not deviate from standard management and follow up protocols and their involvement in the study will require them to attend for additional scans for research purposes.
In order to formulate a research question and methodology the investigators have consulted international and local experts in tissue perfusion who use contrast enhanced ultrasound perfusion and Magnetic Resonance Imaging perfusion techniques. The methodology and research protocols have been developed with clinicians (Vascular surgeons, Interventional Radiologists and Clinical Vascular Scientists) experienced in caring for and treating patients with Peripheral Arterial Disease .
The published literature on tissue perfusion includes research in several organs including the brain, liver, kidneys and with limited but robust data on measuring perfusion in the tissues of the lower limb in people with Peripheral Arterial Disease . There is very limited data on comparing and contrasting the perfusion data produced from two different imaging techniques in the leg muscles within the same cohort. This is extremely important as there is currently no standardised and accepted marker for tissue perfusion to use as a benchmark. Therefore using two techniques will help validate the results.
Through this research a range of values of tissue perfusion will be produced that reflect health and different clinically assessed stages of Peripheral Arterial Disease , as well as provide objective evidence of improved tissue perfusion in patients undergoing routine revascularisation procedures to treat severe Peripheral Arterial Disease .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Exclusion Criteria
- •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.
排除标准
- 未提供
结局指标
主要结局
A novel quantitative imaging biomarker of tissue perfusion
时间窗: 12 months
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.
次要结局
未报告次要终点