NCT05347732

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Apr 2022Jan 2035

First Submitted

Initial submission to the registry

April 20, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
9.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2035

Expected
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

April 20, 2022

Last Update Submit

March 22, 2023

Conditions

STEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Failed thrombolysis

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

    Decided immediately after hospital admission.

Interventions

Successfull thrombolysisDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will include all STEM patients who have received prehospital thrombolysis before hospital admission.

You may qualify if:

  • STEMI patients \> 18 years given prehospital thrombolysis.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ragnhild Helseth, MD PhD

    Department of Cardiology, Oslo University Hospital Ullevål

    STUDY DIRECTOR

Central Study Contacts

Ragnhild Helseth, MD PhD

CONTACT

+47 97 14 95 18ramhel@ous-hf.no

Kristine Kindberg, MD

CONTACT

+4748255362kromoe@ous-hf.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist, PhD

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

April 25, 2022

Primary Completion

April 25, 2025

Study Completion (Estimated)

January 3, 2035

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)