NCT06212921

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

January 4, 2024

Last Update Submit

November 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of correctly predicted cases of acute mesenteric ischaemia

    Rate of correctly predicted cases of Acute mesenteric ischaemia using different biomarkers

    10 months

Study Arms (1)

Patient with suspicion of acute mesenteric ischaemia

OTHER

Bolld samples is the only intervention. All patients with suspicion of AMI will be included and blood samples collected

Diagnostic Test: Sequential blood samples

Interventions

Sequential blood samples for diagnostic tests is the only intervention in thei study

Patient with suspicion of acute mesenteric ischaemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Initial decision in favour of further diagnostics of mesenteric ischaemia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tartu University Hospital

Tartu, 50406, Estonia

RECRUITING

Lucerne Cantonal Hospital

Lucerne, 6000, Switzerland

RECRUITING

Related Publications (1)

  • Tamme K, Acosta S, Biloslavo A, Bjorck M, Casian D, Damaskos D, Forbes A, Kase K, Kisand K, Lakbar I, Mihnovits V, Murruste M, Mandul M, Nuzzo A, Padar M, Starkopf J, Visconti D, Reintam Blaser A. Biomarkers In Prediction of Acute Mesenteric Ischaemia: a prospective multicentre study (BIPAMI study): a study protocol. BMC Surg. 2024 Jul 3;24(1):201. doi: 10.1186/s12893-024-02491-3.

Central Study Contacts

Annika Reintam Blaser, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Sequential blood samples will be collected from study subjects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 19, 2024

Study Start

October 14, 2024

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations