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International Takotsubo Registry (InterTAK Registry) (InterTAK)

This study is currently recruiting participants.
Verified May 2014 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT01947621
First Posted: September 20, 2013
Last Update Posted: May 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of California, Davis
Hannover Medical School
Ludwig-Maximilians - University of Munich
University of Heidelberg Medical Center
University of Schleswig-Holstein
Charite University, Berlin, Germany
University of Kentucky
Medical University of Cologne
University Hospital, Saarland
University Hospital, Essen
Asklepios Kliniken Hamburg GmbH
University Hospital Goettingen
University of Magdeburg
Oxford University Hospitals NHS Trust
Kantonsspital Winterthur KSW
Turku University Hospital
Medical University of Gdansk
Medical University of Warsaw
University Hospital, Basel, Switzerland
Catholic University of the Sacred Heart
Medical University Innsbruck
Cardiocentro Ticino
Luzerner Kantonsspital
Mayo Clinic
Information provided by (Responsible Party):
University of Zurich
  Purpose

This is a multicenter, multinational, prospective and retrospective, observational study of patients with Takotsubo cardiomyopathy (TTC).

Data on natural profile (demographical characteristics, clinical phenotype, laboratory values, electrocardiography parameters, echocardiography parameters, coronary angiography parameters, medication) and outcome are systematically collected.

Our aim is to gain a better insight into the clinical profile and pathophysiology of TTC.


Condition
Takotsubo Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: International Multicenter Registry on Takotsubo Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Natural history of TTC [ Time Frame: 10 years ]
    To determine the natural history of Takotsubo cardiomyopathy.


Secondary Outcome Measures:
  • Cardiovascular complications, recurrence of TTC and all cause mortality [ Time Frame: at hospitalizsation, short term (1 year) and long term (10 years) ]
    Patients will be assessed for cardiovascular complications during hospitalisation and at follow-up (up to 10 years)


Estimated Enrollment: 4000
Study Start Date: January 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Registry is an open-ended study and eligible individuals are assessed at index event and follow-up on their phenotypical characteristics. Furthermore, outcome data are collected (by clinical visits or telephone follow-up).

In addition, participants are given the option to consent to the donation of biosamples for the purposes to identify TTC specific biomarkers and mutations (sub-study on behalf of the registry).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with manifest Takotsubo cardiomyopathy
Criteria

Inclusion criteria: Mayo Clinic Diagnostic Criteria (Prasad et al. American Heart Journal 2008)

  1. Transient hypokinesis, akinesis, or dyskinesis of the left ventricular mid segments with or without apical involvement; the regional wall motion abnormalities extend beyond a single epicardial vascular distribution; a stressful trigger is often, but not always present.*
  2. Absence of obstructive coronary disease or angiographic evidence of acute plaque rupture. †
  3. New electrocardiographic abnormalities (either ST-segment elevation and/or T-wave inversion) or modest elevation in cardiac troponin.

In both of the above circumstances, the diagnosis of TTC should be made with caution, and a clear stressful precipitating trigger must be sought. * There are rare exceptions to these criteria such as those patients in whom the regional wall motion abnormality is limited to a single coronary territory.

† It is possible that a patient with obstructive coronary atherosclerosis may also develop TTC.

Exclusion criteria: Patients with Myocarditis

  Contacts and Locations
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): NCT01947621


Contacts
Contact: Christian Templin, MD, PhD +41 44 255 95 85 christian.templin@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Cardiology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
University of California, Davis
Hannover Medical School
Ludwig-Maximilians - University of Munich
University of Heidelberg Medical Center
University of Schleswig-Holstein
Charite University, Berlin, Germany
University of Kentucky
Medical University of Cologne
University Hospital, Saarland
University Hospital, Essen
Asklepios Kliniken Hamburg GmbH
University Hospital Goettingen
University of Magdeburg
Oxford University Hospitals NHS Trust
Kantonsspital Winterthur KSW
Turku University Hospital
Medical University of Gdansk
Medical University of Warsaw
University Hospital, Basel, Switzerland
Catholic University of the Sacred Heart
Medical University Innsbruck
Cardiocentro Ticino
Luzerner Kantonsspital
Mayo Clinic
Investigators
Principal Investigator: Christian Templin, MD, PhD University Hospital Zurich, Division of Cardiology
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01947621     History of Changes
Other Study ID Numbers: InterTAK Registry
First Submitted: September 9, 2013
First Posted: September 20, 2013
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by University of Zurich:
Broken heart syndrome, stress cardiomyopathy

Additional relevant MeSH terms:
Cardiomyopathies
Takotsubo Cardiomyopathy
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction