Stunning in Takotsubo Versus Acute Myocardial Infarction
Recruiting · NCT04448639 · Observational (researchers observe without assigning treatment) · Lead sponsor: Vastra Gotaland Region
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The Stunning in Takotsubo versus Acute Myocardial Infarction (STAMI) Study Background: Acute myocardial stunning, herein defined as the reversible loss of myocardial function, occurs in both takotsubo syndrome (TS) and ST-elevation myocardial infarction (STEMI), and can be life-threatening in both conditions. However, despite typically having considerably more pronounced myocardial stunning, TS patients have better prognosis than patients with STEMI. Despite the different relationship between extent of myocardial stunning and prognosis in TS vs STEMI, no 'head-to-head' comparison of the myocardial stunning phenotypes in TS vs STEMI has been done. Methods: The Stunning In Takotsubo and Acute Myocardial Infarction (STAMI) study is a single-center, prospective clinical study that will enroll 100 patients with STEMI and 25 patients with TS. Echocardiography, laboratory testing (including troponin and NTpro-BNP), and ECG will be done immediately after angiography and at days 1, 2, 3, 7, 14 and 30. The primary endpoint is the proportion of myocardial stunning that has resolved after 72 hours, as determined by echocardiography. Total myocardial stunning is defined as the extent of akinesia observed at day 0 that resolves by day 30.
Who can take part
Inclusion criteria
- STEMI or TS with planned coronary angiography within 12 hours from the onset of symptoms
- Written consent
Exclusion criteria
- Cardiogenic shock, defined as Killip class IV
- Expected inability to comply with the protocol
Where it is running
1 location listed.
- Department of Cardiology; Sahlgrenska University Hospital - Gothenburg, Sweden