Biomarkers in Prediction of AMI (BIPAMI)

November 27, 2024 updated by: Annika Reintam Blaser, University of Tartu

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Estonia
      • Tartu, Estonia, 50406
        • Recruiting
        • Tartu University Hospital
        • Contact:
          • Joel Starkopf, PhD
          • Phone Number: +3727318405
  • Switzerland
      • Luzern, Switzerland, 6000
        • Recruiting
        • Lucerne Cantonal Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Diagnostic test: Sequential blood samples
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 19, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIPAMI study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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