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NCT05347732 Clinical Trial

Predictors of Failed Thrombolysis in Acute Myocardial Infarction

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— TROFAMI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05347732
Other study ID # 341357
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 25, 2022
Est. completion date January 3, 2035

Study information
Verified date March 2023
Source Oslo University Hospital
Contact Ragnhild Helseth, MD PhD
Phone +47 97 14 95 18
Email ramhel@ous-hf.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 3, 2035
Est. primary completion date April 25, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: STEMI patients > 18 years given prehospital thrombolysis. Exclusion Criteria: None.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Successfull thrombolysis
Biomarker levels will be compared between patients with successful and failed thrombolysis.

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Failed thrombolysis Persistent chest pain and/or < 50 % ST segment resolution Decided immediately after hospital admission.
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