NCT04167904

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,446

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 3, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

3.3 years

First QC Date

September 3, 2018

Last Update Submit

June 4, 2025

Conditions

Myocardial Infarction, Acute

Keywords

Troponin IMyocardial InfarctionSensitivity and SpecificityReceiver operation characteristics curveBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Acute myocardial infarction according to the 4th universal definition of myocardial infarction

    Metric: Yes/No

    Before discharge from hospital, a median of 2 days

Secondary Outcomes (3)

  • Days between hospital discharge and death

    Within 30 days after hospital discharge

  • Days between hospital discharge and acute myocardial infarction according to the 4th universal definition of myocardial infarction

    Within 30 days after hospital discharge

  • Days between hospital discharge and coronary revascularization

    Within 30 days after hospital discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • residency outside Norway
  • does not understand Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs hospital

Trondheim, 7006, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, lithium heparin plasma and EDTA blood

MeSH Terms

Conditions

Myocardial InfarctionHypersensitivity

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisImmune System Diseases

Study Officials

  • Gustav Mikkelsen, MD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2018

First Posted

November 19, 2019

Study Start

December 10, 2019

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

June 8, 2025

Record last verified: 2025-06

Locations

NO(1)