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Predictors of Failed Thrombolysis in Acute Myocardial Infarction

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05347732
Acronym
TROFAMI
Enrollment
200
Registered
2022-04-26
Start date
2022-04-25
Completion date
2035-01-03
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI - ST Elevation Myocardial Infarction

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.

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.

Interventions

DIAGNOSTIC_TESTSuccessfull thrombolysis

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

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

STEMI patients \> 18 years given prehospital thrombolysis.

Exclusion criteria

None.

Design outcomes

Primary

MeasureTime frameDescription
Failed thrombolysisDecided immediately after hospital admission.Persistent chest pain and/or \< 50 % ST segment resolution

Countries

Norway

Contacts

Primary ContactRagnhild Helseth, MD PhD
ramhel@ous-hf.no+47 97 14 95 18
Backup ContactKristine Kindberg, MD
kromoe@ous-hf.no+4748255362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026