Other Clinical Trial - Predictors of Failed Thrombolysis in Acute

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
STEMI - ST Elevation Myocardial Infarction

Clinical Trial Details

NCT number	NCT05347732
Study type	Observational
Source	Oslo University Hospital
Contact	Ragnhild Helseth, MD PhD
Phone	+47 97 14 95 18
Email	ramhel@ous-hf.no
Status	Recruiting
Phase
Start date	April 25, 2022
Completion date	January 3, 2035

View Details

See also
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Terminated	`NCT04459299` - CorPath GRX STEMI Study
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Withdrawn	`NCT04566289` - Observational Registry to Evaluate Real World Usage of PiCSO Impulse System in STEMI Patients as Part of Post-marketing Surveillance
Completed	`NCT04289012` - HELicobacter Pylori Screening in Patients With Acute Myocardial Infarction Pilot Study	N/A
Not yet recruiting	`NCT04185077` - Bivalirudin in Late PCI for Oatients With STEMI	Phase 4
Completed	`NCT03609346` - Asian Registry of the BioFreedom Stent for STEMI Patients
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Recruiting	`NCT02998853` - Non Culprit Functional Evaluation With 3D Angio QFR in STEMI PCI Procedure	N/A
Completed	`NCT03677180` - National Cardiogenic Shock Initiative
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Recruiting	`NCT03863327` - EKG Criteria and Identification of Acute Coronary Occlusion
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Predictors of Failed Thrombolysis in Acute Myocardial Infarction — TROFAMI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms