- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06212921
Biomarkers in Prediction of AMI (BIPAMI)
Biomarkers In Prediction of Acute Mesenteric Ischaemia: a Prospective Multicentre Study (BIPAMI Study)
Current study will be undertaken to identify combinations of biomarkers that can reliably identify acute mesenteric ischaemia (AMI) and distinguish between non-transmural and transmural ischaemia. Different combinations of biomarkers for different sub-types and severity of AMI, and different time points of measurement after onset of symptoms.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tartu, Estonia, 50406
- Tartu University Hospital
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Lucerne, Switzerland, 6000
- Lucerne Cantonal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years or older
- Initial decision in favour of further diagnostics of mesenteric ischaemia
Exclusion Criteria:
- Age <18 years
- Consent declined by patient or next of kin (delayed consent)
- Chronic mesenteric ischaemia without an acute event
- Immediate decision for withdrawal of further diagnostics and active treatment
- Referral from another hospital with already established diagnosis of AMI
- AMI diagnosed at surgery without previously having been considered
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patient with suspicion of acute mesenteric ischaemia
Bolld samples is the only intervention. All patients with suspicion of AMI will be included and blood samples collected |
Sequential blood samples for diagnostic tests is the only intervention in thei study |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of correctly predicted cases of acute mesenteric ischaemia
Time Frame: 10 months
|
Rate of correctly predicted cases of Acute mesenteric ischaemia using different biomarkers |
10 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BIPAMI study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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