International Takotsubo Registry (InterTAK Registry)

Takotsubo Cardiomyopathy Clinical Trial

— InterTAK  

Official title:

International Multicenter Registry on Takotsubo Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01947621
• Other study ID #: InterTAK Registry
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2013
• Last updated: May 20, 2014
• Start date: January 2011
• Est. completion date: December 2020

Study information

• Verified date: May 2014
• Source: University of Zurich
• Contact: Christian Templin, MD, PhD
• Phone: +41 44 255 95 85
• Email: christian.templin[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 2020
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Cardiomyopathies
• Takotsubo Cardiomyopathy

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Cardiology	Zurich	ZH

Sponsors (25)

Lead Sponsor

Collaborator

University of Zurich

Asklepios Kliniken Hamburg GmbH, Cardiocentro Ticino, Catholic University of the Sacred Heart, Charite University, Berlin, Germany, Hannover Medical School, Kantonsspital Winterthur KSW, Ludwig-Maximilians - University of Munich, Luzerner Kantonsspital, Mayo Clinic, Medical University Innsbruck, Medical University of Cologne, Medical University of Gdansk, Medical University of Warsaw, Oxford University Hospitals NHS Trust, Turku University Hospital, University Hospital Goettingen, University Hospital, Basel, Switzerland, University Hospital, Essen, University Hospital, Saarland, University of California, Davis, University of Heidelberg Medical Center, University of Kentucky, University of Magdeburg, University of Schleswig-Holstein

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural history of TTC	To determine the natural history of Takotsubo cardiomyopathy.	10 years	No
Secondary	Cardiovascular complications, recurrence of TTC and all cause mortality	Patients will be assessed for cardiovascular complications during hospitalisation and at follow-up (up to 10 years)	at hospitalizsation, short term (1 year) and long term (10 years)	No

External Links

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