Portal Blood Flow and Oxygen Concentration in Subjects With Chronic Mesenteric Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- flow and oxygen concentration in the portal vein
研究概览
简要总结
In this study the investigators will, with an Magnetic Resonance Imaging (MRI) method, measure the oxygen content in the portal vein, which conduct the blood from the guts to the liver. Examinations will be performed on 20 subjects with meal related abdominal pain due to severe narrowing of the vessels conduction blood to the guts,compared to 20 subjects with similar narrowing of the abdominal vessels, but without meal related pain. The goal of the study is to test a non-invasive, radiation free method to diagnose patients with abdominal pain due to compromized blood supply (chronic mesenteric ischemia).
详细描述
Chronic mesenteric ischemia is a rare but potentially life threatening disease, in which atherosklerotic narrowing of the blood supply to the guts causes meal related abdominal pain, and subsequent weight loss. While the disease is rare, meal related abdominal pain without narrowing of the vessels to the gut is frequently seen, and, conversely, so is narrowing of the vessels to the gut without pain. This makes the diagnosis difficult. For a clinical diagnosis, meal related pain and weight loss > 5 % of Body Mass Index (BMI) is required together with significant stenosis of the mesenteric vessels. These criteria has the drawback that an unknown number of patients with pain due to ischemia, but not weight loss may exist.
The present study will evaluate the extent of mesenteric ischemia by measuring the oxygen content in the portal vein, using functional MRI with an established technique named T2-Relaxation-Under-Spin-Tagging (TRUST).
Two groups of patients will be examined (20 patients in each group)
- With a clinical diagnosis of mesenteric ischemia (pain, weight loss, significant stenosis of mesenteric vessels and relief of symptoms after angioplasty.
- With significant stenosis of the mesenteric vessels, but not meal related pain. The subjects will be examined in a PET-MRI scanner. The flow and oxygen content in the portal vein will be measured in the fasting state and after ingestion of a meal (protein enriched drink). Levels of the gastric peptides GIP, GLP1 and GLP-2 will be evaluated with blood sampling. An injection of 18 F labelled glucose (18F-FDG) will be injected with the purpose of visualising gut sections with reduced uptake due to reduced perfusion with Positron Emission Tomography (PET) scanning.
The primary endpoint will be blood flow and oxygen content in the portal vein, fasting and postprandial, in subjects with mesenteric ischemia defined as improvement of symptoms after angioplasty.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Written informed consent
- •Male or female persons > 18 years
- •Subjects with postprandial abdominal pain considered compatible with mesenteric ischemia, and severe stenosis of the SMA and eventually other mesenteric arteries, diagnosed with CT-angiography or Doppler ultrasound
- •OR subjects with severe stenosis of the SMA and eventually other mesenteric arteries, diagnosed with CT-angiography or Doppler ultrasound, but not postprandial pain
排除标准
- •- Serious concurrent illness
- •BMI > 30
- •Cardiac arrhythmia
- •Anemia with Hgb < 7,0 mmol/l
- •Pregnancy or breastfeeding (urine HCG is performed on all fertile women)
- •Systolic blood pressure < 90 or > 200 mmHg
- •Claustrophobia
- •Patients who, in the judgement of the investigator, is incapable of participating
- •Metallic foreign objects in the body, or pacemakers
结局指标
主要结局
flow and oxygen concentration in the portal vein
时间窗: From enrollment Through study completion, an average of 2 years
Fasting and postprandial flow and oxygen concentration in the portal vein, measured by MRI
次要结局
未报告次要终点
研究者
Ulrik Bjoern Andersen
Principal investigator, MD, Consultant
Rigshospitalet, Denmark