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Stunning in Takotsubo Versus Acute Myocardial Infarction (STAMI)

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ClinicalTrials.gov Identifier: NCT04448639
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Björn Redfors, Vastra Gotaland Region

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.


Condition or disease Intervention/treatment
Myocardial Stunning Diagnostic Test: Echocardigraphy (ECHO) Diagnostic Test: Bloodtest

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.

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: STAMI- Stunning in Takotsubo Versus Acute Myocardial Infarction
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
STEMI
Patients with ST-elevation myocardial Infarction (STEMI) (TS) who undergo urgent coronary angiography within 12 hours of symptom onset.
Diagnostic Test: Echocardigraphy (ECHO)
Standar 12 lead electrocardiogram
Other Name: Standard electrocardigraphy (ECG )

Diagnostic Test: Bloodtest
cardiac biomarkers
Other Name: Troponin and NT-proBNP

TS
Patients with Takotsubo Syndrome (TS) who undergo urgent coronary angiography within 12 hours ofsymptom onset.
Diagnostic Test: Echocardigraphy (ECHO)
Standar 12 lead electrocardiogram
Other Name: Standard electrocardigraphy (ECG )

Diagnostic Test: Bloodtest
cardiac biomarkers
Other Name: Troponin and NT-proBNP




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Relative increase in global longitudinal strain at 3 days vs index [ Time Frame: 3 days ]
    Global longitudinal strain as measured by speckle tracking echocardiography.

  2. Global longitudinal strain at 0, 1, 2, 3, 7, 14 and 30 days [ Time Frame: Days 0, 1, 2, 3, 7, 14, 30 days ]
    Global longitudinal strain as measured by speckle tracking echocardiography.

  3. Regional radial strain in the unaffected contralateral myocardial wall at days 0, 1, 2, 3, 7, 14 and 30 [ Time Frame: Days 0, 1, 2, 3, 7, 14 and 30 ]
    Radial longitudinal strain as measured by speckle tracking echocardiography.

  4. Major adverse cardiac events at 30 days and 1 year [ Time Frame: Days 30 and 365 ]
    Major adverse cardiac event is defined as all-cause death, stroke, myocardial infarction or rehospitalization for heart failure.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with STEMI or TS who undergo urgent coronary angiography within 12 hours of symptom onset.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448639


Locations
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Sweden
Department of Cardiology; Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Björn Redfors, MD, PhD    004631-342 7560;    Bjoern.Redfors@wlab.gu.se   
Contact: Sandeep Jha, MD    0046738491912    sandeep.jha@vgregion.se   
Principal Investigator: Björn Redfors, MD, PhD         
Sub-Investigator: Sandeep Jha, MD         
Sub-Investigator: Emanuele Bobbio, MD         
Sub-Investigator: Sigurdur Thorleifsson, MD         
Sub-Investigator: Thomas Mellberg, MD         
Sub-Investigator: Rickard Zeijlon, MD         
Sponsors and Collaborators
Vastra Gotaland Region
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Responsible Party: Björn Redfors, Doctor of medicine, PhD; Associate Proffessor, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT04448639    
Other Study ID Numbers: Dnr 2019-04092
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Björn Redfors, Vastra Gotaland Region:
Myocardial Stunning
Acute heart failure
Taoktsubo Syndrome
Acute myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Stunning
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms