Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction (BIOMAC)

April 21, 2023 updated by: St. Olavs Hospital
The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. The primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin I in diagnosing acute myocardial infarction.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

4446

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 Contact Backup

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • St Olavs Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to St. Olavs Hospital (Trondheim University Hospital) with suspected acute myocardial infarction without ST-elevations on ECG (NSTEMI).

Description

Inclusion Criteria:

  • hospitalized at St. Olavs hospital
  • blood sampled for troponin analysis due to suspicion of acute myocardial infarction without ST-elevations on ECG less than 4 hours after admitted to the hospital

Exclusion Criteria:

  • residency outside Norway
  • does not understand Norwegian

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute myocardial infarction according to the 4th universal definition of myocardial infarction
Time Frame: Before discharge from hospital, a median of 2 days
Metric: Yes/No
Before discharge from hospital, a median of 2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days between hospital discharge and death
Time Frame: Within 30 days after hospital discharge
Metric: Days. The secondary outcome measures will be combined into a composite endpoint reflecting the time between hospital admission and the first secondary outcome measure
Within 30 days after hospital discharge
Days between hospital discharge and acute myocardial infarction according to the 4th universal definition of myocardial infarction
Time Frame: Within 30 days after hospital discharge
Metric: Days.
Within 30 days after hospital discharge
Days between hospital discharge and coronary revascularization
Time Frame: Within 30 days after hospital discharge
Metric: Days
Within 30 days after hospital discharge

Collaborators and Investigators

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

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Principal Investigator: Gustav Mikkelsen, MD, St. Olavs Hospital

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)

January 15, 2020

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

November 15, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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