PRomoting Early Diagnosis Of Chronic Mesenteric ISchEmia by a Mesenteric Artery Calcium Score Based Risk Stratification and Detection of Postprandial Mucosal Ischemia by Butyrate Breath Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 296
- 试验地点
- 4
- 主要终点
- Breath test
研究概览
简要总结
CMI is an incapacitating disease and timely diagnosis remains problematic. Despite the substantial compensatory capacity of the mesenteric circulation CMI is relatively common, its incidence being comparable to other well-known diseases like Crohn's disease.
Diagnostic tools are needed for two purposes since the exclusion of CMI currently requires a cumbersome complication-prone diagnostic workup and since a definitive diagnosis is mainly established per exclusionem. First, a sensitive test is desirable to rule out CMI and avoid excessive diagnostic investigations. Quantification of mesenteric arterial calcification on computed tomography (CT) seems suitable for this purpose, synonymous with the coronary artery calcium score. Second, a specific test is required confirming CMI by detection of mucosal ischemia during a meal, when oxygen demand peaks. A breath test, based on the requirement of oxygen to absorb and metabolize 13C-butyrate in the enterocyte, could detect mucosal ischemia
Objective: Facilitating diagnosis of chronic mesenteric ischemia (CMI) using 1) the mesenteric artery calcium score (MACS) and 2) mucosal ischemia detection by butyrate breath testing
Study design: Multicentre prospective cohort studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with a clinical suspicion of CMI referred to Maagdarm Ischemie Centrum Rotterdam (MICR), MST or UMCG.
- •Patients ≥ 18 years
排除标准
- •Patients who are unable to give informed consent
- •Patients with previous mesenteric artery revascularization
- •No available CT imaging and contraindications for CT imaging (e.g. pregnancy)
- •Common origin of the celiac artery and superior mesenteric artery
- •Known delayed gastric emptying
- •Known and untreated small intestinal bacterial overgrowth
结局指标
主要结局
Breath test
时间窗: 2023-2025
- To validate the butyrate breath test as a specific functional test with a high positive predictive value to rightfully diagnose and select patients who will benefit from invasive treatment.
calcium scores
时间窗: 2023-2035
To validate the mesenteric artery calcium score as a readily available, easy, and sensitive test with a high negative predictive value to either rule out CMI or select patients for further investigations.
次要结局
未报告次要终点
研究者
Marco J. Bruno
Gastroenterologist
Erasmus Medical Center