Predictors of Failed Thrombolysis in Acute Myocardial Infarction

NCT ID: NCT05347732

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2035-01-03

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Successfull thrombolysis

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

STEMI patients > 18 years given prehospital thrombolysis.

Exclusion Criteria

None.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ragnhild Helseth

Cardiologist, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ragnhild Helseth, MD PhD

Role: STUDY_DIRECTOR

Department of Cardiology, Oslo University Hospital Ullevål

Locations

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Ragnhild Helseth, MD PhD

Role: CONTACT

ramhel@ous-hf.no

+47 97 14 95 18

Kristine Kindberg, MD

Role: CONTACT

kromoe@ous-hf.no

+4748255362

Facility Contacts

Ragnhild Helseth, MD PhD

Role: primary

ramhel@ous-hf.no

+4797149518

Other Identifiers

341357

Identifier Type: -

Identifier Source: org_study_id