Stunning in Takotsubo Versus Acute Myocardial Infarction
STAMI
STAMI- Stunning in Takotsubo Versus Acute Myocardial Infarction
1 other identifier
observational
125
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2019
CompletedFirst Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
ExpectedDecember 12, 2023
December 1, 2023
4.1 years
June 3, 2020
December 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of stunning that has resolved at 3 days versus 14 days
StunningResolution at 3 days is defined as StunningRes3D = (%Akinesia Baseline - %Akinesia 3day) / (%Akinesia Baseline - %Akinesia 30days); where %Akinesia is calculated as the endocardial length of the akinetic left ventricular myocardium divided by the total endocardial length of the left ventricular myoocardium - as assessed in the apical 2-chamber and 4-chamber views at end-diastole. The recovery of stunning at 3 days is compared to the recovery of stunning at 30 days. Thus a 14 day timeframe is required.
30 days
Secondary Outcomes (6)
Change in wall motion score index
30 days
Change in left ventricular ejection fraction
30 days
Change in global longitudinal strain
30 days
Change in radial strain in the unaffected contralateral myocardial wall
30 days
Change in serum troponin-I:troponin:T ratio
30 days
- +1 more secondary outcomes
Study Arms (2)
STEMI
Patients with ST-elevation myocardial Infarction (STEMI) (TS) who undergo urgent coronary angiography within 12 hours of symptom onset.
TS
Patients with Takotsubo Syndrome (TS) who undergo urgent coronary angiography within 12 hours ofsymptom onset.
Interventions
Standar 12 lead electrocardiogram
Eligibility Criteria
Patients with STEMI or TS who undergo urgent coronary angiography within 12 hours of symptom onset.
You may qualify if:
- STEMI or TS with planned coronary angiography within 12 hours from the onset of symptoms
- Written consent
You may not qualify if:
- Cardiogenic shock, defined as Killip class IV
- Expected inability to comply with the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology; Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Related Publications (1)
Jha S, Poller A, Shekka Espinosa A, Molander L, Sevastianova V, Zeijlon R, Simons K, Bobbio E, Pirazzi C, Martinsson A, Mellberg T, Gudmundsson T, Torild P, Sundstrom J, Andersson EA, Thorleifsson S, Salahuddin S, Elmahdy A, Pylova T, Rawshani A, Angeras O, Ramunddal T, Skoglund K, Omerovic E, Redfors B. Prospective comparison of temporal changes in myocardial function in women with Takotsubo versus anterior STEMI. Clin Res Cardiol. 2025 Dec;114(12):1705-1717. doi: 10.1007/s00392-025-02633-4. Epub 2025 Mar 20.
PMID: 40111441DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor of medicine, PhD; Associate Proffessor
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 26, 2020
Study Start
December 12, 2019
Primary Completion
January 1, 2024
Study Completion (Estimated)
December 1, 2030
Last Updated
December 12, 2023
Record last verified: 2023-12