Myocardial StunningSTAMINCT04448639
Stunning in Takotsubo Versus Acute Myocardial Infarction
An observational study of Myocardial Stunning, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Stunning
- What is being tested?
- Echocardigraphy (ECHO) and Bloodtest
- How many people
- 125 participants
- Where
- 1 siteSweden
- Study dates
- 12 Dec 2019to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with STEMI or TS who undergo urgent coronary angiography within 12 hours of symptom onset.
Who may be able to join
- STEMI or TS with planned coronary angiography within 12 hours from the onset of symptoms
- Written consent
Who cannot join
- Cardiogenic shock, defined as Killip class IV
- Expected inability to comply with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Cardiology; Sahlgrenska University Hospital
Gothenburg, 413 45
Björn Redfors, MD, PhD, 004631-342 7560;, Bjoern.Redfors@wlab.gu.se
Sandeep Jha, MD, 0046738491912, sandeep.jha@vgregion.se
About this study
Official title: STAMI- Stunning in Takotsubo Versus Acute Myocardial Infarction
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.
Read the detailed description
Prospective assessment of the temporal electrocardiographic-, vectorcardiographic- and echocardiographic changes in STelevation myocardial infarction versus the takotsubo syndrome.
AIM To compare the temporal pattern of myocardial funtional recovery after ST-elevation myocardial infarction (STEMI) versus the takotsubo syndrome (TS).
BACKGROUND Modern therapies have reduced the incidence of acute ischemic heart failure (AIHF) -But AIHF is still common and once it develops prognosis remains dismal.Despite considerable therapeutic advancements over the last decades, acute myocardialinfarction (AMI) remains one of the most common causes of death . Among patients who are admitted with AMI, the 10% that develop AIHF account for approximately 50% of Deaths within 30 days . The prognosis for patients with AIHF has not improved over the last decade . AIHF occurs due to acute loss of cardiac function, some of which occurs in myocardium that is not irreparably damaged - so called stunned myocardium.
Myocardial stunning in AIHF - Temporary mechanical dysfunction without irreparable injury. Myocardial stunning was originally described in the setting of ischemia and was defined as temporary mechanical dysfunction that persists after resolution of ischemia, with the absence of irreversible histological damage . For the purpose of this application it is more broadly defined as temporary mechanical dysfunction, with the absence of irreversible histological damage - irrespective of the underlying cause. Myocardial stunning is believed to be a harmful phenomenon caused by cellular injury .
Study hypothesis: Myocardial stunning is a protective mechanism by which the cardiomyocytes preserve energy for vital processes in states of severe cellular stress - but that can "overshoot" and lead to potentially lethal cardiac decompensation. In the normal heart, the contractile apparatus consumes the majority of myocardial energy and oxygen . Non-contractile myocardial functions, including cellular and electrical homeostasis, require less than 20% as much oxygen. When oxygen supply to the heart is interrupted myocardial stunning ensues within seconds, whereas it takes at least 10 minutes for the cardiomyocyte's energy metabolites to decrease to 50% of their initial level .Hence, by shutting down the contractile apparatus before it consumes the cells' energy stores myocardial stunning effectively preserves energy for processes that are necessary for cell survival . Irrespective of its beneficial effects on cardiomyocyte metabolism, myocardial stunning may lead to sufficiently pronounced cardiac dysfunction to cause life-threatening AIHF.
Study purpose:
To better understand the difference between myocardial stunning in STEMI and the more benign form of stunning in TS. The sudden occurrence of temporary myocardial mechanical dysfunction with the absence of irreversible myocardial damage is not limited to AMI. It can occur postoperatively after cardiac arrest; in the settings of acute myocarditis and tachycardia-induced cardiomyopathy; and as a consequence of severe emotional or somatic stress in the takotsubo syndrome .Intriguingly, takotsubo is characterized by a compensated hemodynamic profile despite extensive myocardial dysfunction, effective recovery of myocardial function within days orweeks, and a relatively good prognosis .Takotsubo therefore appears to be a more efficient form of stunning than AIHF. Better understanding of the mechanisms behind the stunning phenomenon could allow for manipulation of the stunning phenotype in AIHF, or for pharmacological reversal of myocardial stunning once coronary reperfusion and adequate myocardial energy delivery has been ensured.
- Conditions
- Myocardial Stunning
- Being tested
- Echocardigraphy (ECHO), Bloodtest
- Keywords
- Myocardial Stunning, Acute heart failure, Taoktsubo Syndrome, Acute myocardial infarction
- Medical subject headings
- Myocardial Stunning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardigraphy (ECHO)Diagnostic test
Also called Standard electrocardigraphy (ECG )
Standar 12 lead electrocardiogram
BloodtestDiagnostic test
Also called Troponin and NT-proBNP
cardiac biomarkers
| Study group | Role | What they receive |
|---|---|---|
| STEMI | Patients with ST-elevation myocardial Infarction (STEMI) (TS) who undergo urgent coronary angiography within 12 hours of symptom onset. Receives: Diagnostic Test: Echocardigraphy (ECHO); Diagnostic Test: Bloodtest | |
| TS | Patients with Takotsubo Syndrome (TS) who undergo urgent coronary angiography within 12 hours ofsymptom onset. Receives: Diagnostic Test: Echocardigraphy (ECHO); Diagnostic Test: Bloodtest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (6)
Change in wall motion score index
Myocardial wall motion score index
Measured: 30 days
Change in left ventricular ejection fraction
left ventricular ejection fraction as measured by speckle tracking echocardiography.
Measured: 30 days
Change in global longitudinal strain
Global longitudinal strain as measured by speckle tracking echocardiography.
Measured: 30 days
Change in radial strain in the unaffected contralateral myocardial wall
Radial longitudinal strain as measured by speckle tracking echocardiography.
Measured: 30 days
Change in serum troponin-I:troponin:T ratio
The ratio between serum troponin-1 and serum troponin-T
Measured: 30 days
Change in serum NT proBNP
Serum NT proBNP
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start12 Dec 2019
- Primary completionJan 2024 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial StunningStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Björn Redfors, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448639
- Sponsor's protocol ID
- Dnr 2019-04092
- Acronym
- STAMI
- Status last verified
- Dec 2023
- First submitted
- 3 Jun 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Poller A, Jha S, Thorleifsson SJ, Espinosa AS, Sevastianova V, Molander L, Andersson EA, Zeijlon R, Simons K, Omerovic E, Bech-Hanssen O, Redfors B. Left ventricular diastolic function over the acute and subacute phase in the Takotsubo syndrome versus ST-elevation myocardial infarction. Int J Cardiol. 2026 Aug 1;456:134522. doi: 10.1016/j.ijcard.2026.134522. Epub 2026 Apr 25.
PubMed 42044717Jha 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.
PubMed 40111441
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAMI- Stunning in Takotsubo Versus Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04448639
- Acronym / sponsor ID
- STAMI / Dnr 2019-04092
- Conditions
- Myocardial Stunning
- Keywords
- Myocardial Stunning, Acute heart failure, Taoktsubo Syndrome, Acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective assessment of the temporal electrocardiographic-, vectorcardiographic- and echocardiographic changes in STelevation myocardial infarction versus the takotsubo syndrome.
AIM To compare the temporal pattern of myocardial funtional recovery after ST-elevation myocardial infarction (STEMI) versus the takotsubo syndrome (TS).
BACKGROUND Modern therapies have reduced the incidence of acute ischemic heart failure (AIHF) -But AIHF is still common and once it develops prognosis remains dismal.Despite considerable therapeutic advancements over the last decades, acute myocardialinfarction (AMI) remains one of the most common causes of death . Among patients who are admitted with AMI, the 10% that develop AIHF account for approximately 50% of Deaths within 30 days . The prognosis for patients with AIHF has not improved over the last decade . AIHF occurs due to acute loss of cardiac function, some of which occurs in myocardium that is not irreparably damaged - so called stunned myocardium.
Myocardial stunning in AIHF - Temporary mechanical dysfunction without irreparable injury. Myocardial stunning was originally described in the setting of ischemia and was defined as temporary mechanical dysfunction that persists after resolution of ischemia, with the absence of irreversible histological damage . For the purpose of this application it is more broadly defined as temporary mechanical dysfunction, with the absence of irreversible histological damage - irrespective of the underlying cause. Myocardial stunning is believed to be a harmful phenomenon caused by cellular injury .
Study hypothesis: Myocardial stunning is a protective mechanism by which the cardiomyocytes preserve energy for vital processes in states of severe cellular stress - but that can "overshoot" and lead to potentially lethal cardiac decompensation. In the normal heart, the contractile apparatus consumes the majority of myocardial energy and oxygen . Non-contractile myocardial functions, including cellular and electrical homeostasis, require less than 20% as much oxygen. When oxygen supply to the heart is interrupted myocardial stunning ensues within seconds, whereas it takes at least 10 minutes for the cardiomyocyte's energy metabolites to decrease to 50% of their initial level .Hence, by shutting down the contractile apparatus before it consumes the cells' energy stores myocardial stunning effectively preserves energy for processes that are necessary for cell survival . Irrespective of its beneficial effects on cardiomyocyte metabolism, myocardial stunning may lead to sufficiently pronounced cardiac dysfunction to cause life-threatening AIHF.
Study purpose:
To better understand the difference between myocardial stunning in STEMI and the more benign form of stunning in TS. The sudden occurrence of temporary myocardial mechanical dysfunction with the absence of irreversible myocardial damage is not limited to AMI. It can occur postoperatively after cardiac arrest; in the settings of acute myocarditis and tachycardia-induced cardiomyopathy; and as a consequence of severe emotional or somatic stress in the takotsubo syndrome .Intriguingly, takotsubo is characterized by a compensated hemodynamic profile despite extensive myocardial dysfunction, effective recovery of myocardial function within days orweeks, and a relatively good prognosis .Takotsubo therefore appears to be a more efficient form of stunning than AIHF. Better understanding of the mechanisms behind the stunning phenomenon could allow for manipulation of the stunning phenotype in AIHF, or for pharmacological reversal of myocardial stunning once coronary reperfusion and adequate myocardial energy delivery has been ensured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI | – | Diagnostic Test: Echocardigraphy (ECHO), Diagnostic Test: BloodtestPatients with ST-elevation myocardial Infarction (STEMI) (TS) who undergo urgent coronary angiography within 12 hours of symptom onset. |
| TS | – | Diagnostic Test: Echocardigraphy (ECHO), Diagnostic Test: BloodtestPatients with Takotsubo Syndrome (TS) who undergo urgent coronary angiography within 12 hours ofsymptom onset. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with STEMI or TS who undergo urgent coronary angiography within 12 hours of symptom onset.
Key inclusion criteria (2 listed)
- STEMI or TS with planned coronary angiography within 12 hours from the onset of symptoms
- Written consent
Key exclusion criteria (2 listed)
- Cardiogenic shock, defined as Killip class IV
- Expected inability to comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardigraphy (ECHO)Also: Standard electrocardigraphy (ECG )Standar 12 lead electrocardiogram | Diagnostic test | STEMI, TS |
| BloodtestAlso: Troponin and NT-proBNPcardiac biomarkers | Diagnostic test | STEMI, TS |
Primary outcome
Proportion of stunning that has resolved at 3 days versus 14 days
Time frame: 30 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.
6 secondary outcomes
Change in wall motion score index
Time frame: 30 days
Change in left ventricular ejection fraction
Time frame: 30 days
Change in global longitudinal strain
Time frame: 30 days
Change in radial strain in the unaffected contralateral myocardial wall
Time frame: 30 days
Change in serum troponin-I:troponin:T ratio
Time frame: 30 days
Change in serum NT proBNP
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 42044717Poller A, Jha S, Thorleifsson SJ, Espinosa AS, Sevastianova V, Molander L, Andersson EA, Zeijlon R, Simons K, Omerovic E, Bech-Hanssen O, Redfors B. Left ventricular diastolic function over the acute and subacute phase in the Takotsubo syndrome versus ST-elevation myocardial infarction. Int J Cardiol. 2026 Aug 1;456:134522. doi: 10.1016/j.ijcard.2026.134522. Epub 2026 Apr 25.
- Derived from this study: PubMed 40111441Jha 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Cardiology; Sahlgrenska University Hospital
Gothenburg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Stunning, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of stunning that has resolved at 3 days versus 14 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448639, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.