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

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 - PROMISE study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53338

Enrollment

296

Registered

2023-01-09

Start date

2024-02-01

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic mesenteric ischemia intestinal oxygen shortage Chronic mesenteric ischemia, lack of oxygen in the intestines

Interventions

butyrateb breath test&nbsp

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients >= 18 years - Patients with a clinical suspicion of CMI referred to the hospital

Exclusion criteria

Exclusion criteria: - Patients who are unable to give informed consent - No available CT imaging and contraindications for CT imaging (e.g. pregnancy) - Patients with previous mesenteric artery revascularization - Common origin of the celiac artery and superior mesenteric artery - Known delayed gastric emptying - Known and untreated small intestinal bacterial overgrowth

Design outcomes

Primary

Measure	Time frame
1) MACS: An existing abdominal CT is used to calculate the MACS of the celiac artery and superior mesenteric artery. 2) Butyrate breath testing: Patients will receive 13C-butyrate dissolved in a high caloric drink (Nutridrink). Multiple test tubes filled with expired air of 13CO2 will be collected during a period of 2 hours.	—

Secondary

Measure	Time frame
- To determine cut of values for the MACS with high specificity and high negative predictive value. - To validate the symptom and CT based MACS score chart for early risk stratification of patients with suspected CMI. - To investigate how CMI affects the gut microbioma and which specific microbial DNA fragments in blood can indicate ischemic damage to the intestinal tissue measured before and after stentplacement - To assess if specific DNA fragments in blood, associated with cell death due to ischemia, could serve as potential biomarkers for the severity and presence of CMI - To investigate the difference of cytokeratin fragments in blood before and after stent placement, and which fragments can serve as diagnostic markers for the type and location of cell death in intestinal ischemia?	—

Measure

Time frame

- To determine cut of values for the MACS with high specificity and high negative predictive value. - To validate the symptom and CT based MACS score chart for early risk stratification of patients with suspected CMI. - To investigate how CMI affects the gut microbioma and which specific microbial DNA fragments in blood can indicate ischemic damage to the intestinal tissue measured before and after stentplacement - To assess if specific DNA fragments in blood, associated with cell death due to ischemia, could serve as potential biomarkers for the severity and presence of CMI - To investigate the difference of cytokeratin fragments in blood before and after stent placement, and which fragments can serve as diagnostic markers for the type and location of cell death in intestinal ischemia?

—

Countries

Netherlands

Contacts

Public ContactE.K. Bocharewicz

Erasmus MC, Universitair Medisch Centrum Rotterdam

e.bocharewicz@erasmusmc.nl0652216196

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)