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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

Tracking Information
First Submitted Date June 3, 2020
First Posted Date June 26, 2020
Last Update Posted Date July 23, 2020
Actual Study Start Date December 12, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2020)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 22, 2020)
  • Relative increase in global longitudinal strain at 3 days vs index [ Time Frame: 3 days ]
    Global longitudinal strain as measured by speckle tracking echocardiography.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stunning in Takotsubo Versus Acute Myocardial Infarction
Official Title STAMI- Stunning in Takotsubo Versus Acute Myocardial Infarction
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.

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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with STEMI or TS who undergo urgent coronary angiography within 12 hours of symptom onset.
Condition Myocardial Stunning
Intervention
  • Diagnostic Test: Echocardigraphy (ECHO)
    Standar 12 lead electrocardiogram
    Other Name: Standard electrocardigraphy (ECG )
  • Diagnostic Test: Bloodtest
    cardiac biomarkers
    Other Name: Troponin and NT-proBNP
Study Groups/Cohorts
  • STEMI
    Patients with ST-elevation myocardial Infarction (STEMI) (TS) who undergo urgent coronary angiography within 12 hours of symptom onset.
    Interventions:
    • Diagnostic Test: Echocardigraphy (ECHO)
    • Diagnostic Test: Bloodtest
  • TS
    Patients with Takotsubo Syndrome (TS) who undergo urgent coronary angiography within 12 hours ofsymptom onset.
    Interventions:
    • Diagnostic Test: Echocardigraphy (ECHO)
    • Diagnostic Test: Bloodtest
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 21, 2020)
125
Original Estimated Enrollment
 (submitted: June 22, 2020)
550
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04448639
Other Study ID Numbers Dnr 2019-04092
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Björn Redfors, Vastra Gotaland Region
Study Sponsor Vastra Gotaland Region
Collaborators Not Provided
Investigators Not Provided
PRS Account Vastra Gotaland Region
Verification Date July 2020