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International Takotsubo Registry (InterTAK Registry) (InterTAK)

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ClinicalTrials.gov Identifier: NCT01947621
Recruitment Status : Recruiting
First Posted : September 20, 2013
Last Update Posted : May 21, 2014
Sponsor:
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

Tracking Information
First Submitted Date September 9, 2013
First Posted Date September 20, 2013
Last Update Posted Date May 21, 2014
Study Start Date January 2011
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 17, 2013)
Natural history of TTC [ Time Frame: 10 years ]
To determine the natural history of Takotsubo cardiomyopathy.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2014)
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)
Original Secondary Outcome Measures
 (submitted: September 17, 2013)
Cardiovascular complications, recurrence of TTC and all cause mortality [ Time Frame: at hospitalizsation and long term (10 years) ]
Patients will be assessed for cardiovascular complications during hospitalisation and at follow-up (up to 10 years)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Takotsubo Registry (InterTAK Registry)
Official Title International Multicenter Registry on Takotsubo Cardiomyopathy
Brief Summary

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.

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).

Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals with manifest Takotsubo cardiomyopathy
Condition Takotsubo Cardiomyopathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   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: September 17, 2013)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christian Templin, MD, PhD +41 44 255 95 85 christian.templin@usz.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01947621
Other Study ID Numbers InterTAK Registry
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
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
Investigators
Principal Investigator: Christian Templin, MD, PhD University Hospital Zurich, Division of Cardiology
PRS Account University of Zurich
Verification Date May 2014