Myocardial Infarction, Acute Clinical Trial
— BIOMACOfficial title:
Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction
| NCT number | NCT04167904 |
| Other study ID # | 2018/648 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 15, 2020 |
| Est. completion date | April 1, 2023 |
| Verified date | April 2023 |
| Source | St. Olavs Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The concentration of troponins in plasma is used for diagnosing acute myocardial infarction. Different types of heart-specific troponins can be measured and with different analytical methods. The primary aim of this study is to evaluate the diagnostic characteristics of a new analytical method for measuring troponin I in diagnosing acute myocardial infarction.
| Status | Completed |
| Enrollment | 4446 |
| Est. completion date | April 1, 2023 |
| Est. primary completion date | April 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - hospitalized at St. Olavs hospital - blood sampled for troponin analysis due to suspicion of acute myocardial infarction without ST-elevations on ECG less than 4 hours after admitted to the hospital Exclusion Criteria: - residency outside Norway - does not understand Norwegian |
| Country | Name | City | State |
|---|---|---|---|
| Norway | St Olavs hospital | Trondheim |
| Lead Sponsor | Collaborator |
|---|---|
| St. Olavs Hospital | Norwegian University of Science and Technology |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Acute myocardial infarction according to the 4th universal definition of myocardial infarction | Metric: Yes/No | Before discharge from hospital, a median of 2 days | |
| Secondary | Days between hospital discharge and death | Metric: Days. The secondary outcome measures will be combined into a composite endpoint reflecting the time between hospital admission and the first secondary outcome measure | Within 30 days after hospital discharge | |
| Secondary | Days between hospital discharge and acute myocardial infarction according to the 4th universal definition of myocardial infarction | Metric: Days. | Within 30 days after hospital discharge | |
| Secondary | Days between hospital discharge and coronary revascularization | Metric: Days | Within 30 days after hospital discharge |
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