TROFAMI: Predictors of Failed Thrombolysis in Acute Myocardial Infarction

Sponsor

Oslo University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05347732

Collaborator

(none)

200

Enrollment

152.3

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this observational study is to assess why thrombolytic treatment with tissue-plasminogen activator (t-PA) fails in patients with acute ST-segment elevation myocardial infarction (STEMI). The study will include 200 STEMI patients at the time of arrival at Oslo University Hospital Ullevål after receiving prehospital thrombolysis. A blood sample will be taken immediately for the study of factors related to coagulation, fibrinolysis and inflammation. Levels of the biomarkers will be compared between patients with successful and failed thrombolysis.

Condition or Disease	Intervention/Treatment	Phase
STEMI - ST Elevation Myocardial Infarction	Diagnostic Test: Successfull thrombolysis

Detailed Description

This study aims to explore why thrombolytic treatment with tissue-plasminogen activator (t-PA) fails in up to 50 % of pasients with acute ST-segment elevation myocardial infarction (STEMI). This is important in Norway due to the long geographic distances and the fact that up to 70 % of STEMI patients in some Norwegian areas receive thrombolysis in stead of primary, invasive revascularization with percutaneous coronary intervention (PCI). Today, no well-defined biomarker or score can predict the successfulness of thrombolytic therapy during STEMI. As failed thrombolysis leads to larger myocardial infarctions and poorer outcome, defining factors for improved risk stratification is important.

The TROFAMI study is a prospective study which will include 200 STEMI patients given prehospital thrombolysis. A blood sample will be taken immediately after hospital admission for the analysis of potential relevant biomarkers related to coagulation, fibrinolysis and inflammation. The biomarkers will be evaluated against the successfullness or not of thrombolysis.

Oslo University Hospital is the largest STEMI center in Norway. Each year, approximately 100 STEMI patients given prehospital thrombolysis are hospitalized at Ullevål. The inclusion is anticipated to take place during the time period 2022-2024.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Predictors of Failed Thrombolysis in Acute ST-segment Elevation Myocardial Infarction

Anticipated Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Apr 25, 2025

Anticipated Study Completion Date :

Jan 3, 2035

Outcome Measures

Primary Outcome Measures

Failed thrombolysis [Decided immediately after hospital admission.]
Persistent chest pain and/or < 50 % ST segment resolution

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

STEMI patients > 18 years given prehospital thrombolysis.

Exclusion Criteria:

None.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Oslo University Hospital

Investigators

Study Director: Ragnhild Helseth, MD PhD, Department of Cardiology, Oslo University Hospital Ullevål

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ragnhild Helseth, Cardiologist, PhD, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT05347732

Other Study ID Numbers:

341357

First Posted:

Apr 26, 2022

Last Update Posted:

Apr 26, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myocardial Infarction

ST Elevation Myocardial Infarction

Infarction

Study Results

No Results Posted as of Apr 26, 2022