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NCT Number: NCT05347732

Predictors of Failed Thrombolysis in Acute Myocardial Infarction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

Location status: Recruiting

Location contact

Ragnhild Helseth, MD PhD

CONTACT

[email protected]

+4797149518

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

STEMI patients > 18 years given prehospital thrombolysis.

Exclusion criteria

None.

Treatment and study plan

Successfull thrombolysis

Diagnostic Test

Biomarker levels will be compared between patients with successful and failed thrombolysis.

Primary outcomes

  1. Failed thrombolysis

    Time frame: Decided immediately after hospital admission.

    Persistent chest pain and/or < 50 % ST segment resolution

Study contacts

Contact information is provided by the study sponsor or research team.

Kristine Kindberg, MD

CONTACT

[email protected]

+4748255362

Ragnhild Helseth, MD PhD

CONTACT

[email protected]

+47 97 14 95 18

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: TROFAMI

Important dates

Study start
2022
Primary completion
2025
Study completion
2035
First posted
Apr 26, 2022
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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