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International Takotsubo Registry (InterTAK Registry) (InterTAK)

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.
 
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

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.


Condition or disease
Takotsubo Cardiomyopathy

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).

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Official Title: International Multicenter Registry on Takotsubo Cardiomyopathy
Study Start Date : January 2011
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy




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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


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

Locations
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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
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Principal Investigator: Christian Templin, MD, PhD University Hospital Zurich, Division of Cardiology
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Napp LC, Cammann VL, Jaguszewski M, Szawan KA, Wischnewsky M, Gili S, Knorr M, Heiner S, Citro R, Bossone E, D'Ascenzo F, Neuhaus M, Franke J, Sorici-Barb I, Noutsias M, Burgdorf C, Koenig W, Kherad B, Sarcon A, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Pott A, Meyer P, Arroja JD, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Hauck C, Paolini C, Bilato C, Imori Y, Kato K, Kobayashi Y, Opolski G, Budnik M, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Dichtl W, Chan C, Bridgman P, Beug D, Delmas C, Lairez O, El-Battrawy I, Akin I, Gilyarova E, Shilova A, Gilyarov M, Horowitz JD, Polednikova K, Tousek P, Widimský P, Winchester DE, Galuszka J, Ukena C, Poglajen G, Carrilho-Ferreira P, Di Mario C, Prasad A, Rihal CS, Schulze PC, Bianco M, Crea F, Borggrefe M, Maier LS, Pinto FJ, Braun-Dullaeus RC, Rottbauer W, Katus HA, Hasenfuß G, Tschöpe C, Pieske BM, Thiele H, Schunkert H, Böhm M, Felix SB, Münzel T, Bax JJ, Bauersachs J, Braunwald E, Lüscher TF, Ruschitzka F, Ghadri JR, Templin C. Coexistence and outcome of coronary artery disease in Takotsubo syndrome. Eur Heart J. 2020 Jun 2. pii: ehaa210. doi: 10.1093/eurheartj/ehaa210. [Epub ahead of print]
D'Ascenzo F, Gili S, Bertaina M, Iannaccone M, Cammann VL, Di Vece D, Kato K, Saglietto A, Szawan KA, Frangieh AH, Boffini B, Annaratone M, Sarcon A, Levinson RA, Franke J, Napp LC, Jaguszewski M, Noutsias M, Münzel T, Knorr M, Heiner S, Katus HA, Burgdorf C, Schunkert H, Thiele H, Bauersachs J, Tschöpe C, Pieske BM, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Hasenfuß G, Karakas M, Koenig W, Rottbauer W, Said SM, Braun-Dullaeus RC, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Crea F, Dichtl W, Franz WM, Empen K, Felix SB, Delmas C, Lairez O, El-Battrawy I, Akin I, Borggrefe M, Horowitz JD, Kozel M, Tousek P, Widimský P, Gilyarova E, Shilova A, Gilyarov M, Biondi-Zoccai G, Winchester DE, Ukena C, Neuhaus M, Bax JJ, Prasad A, Di Mario C, Böhm M, Gasparini M, Ruschitzka F, Bossone E, Citro R, Rinaldi M, De Ferrari GM, Lüscher T, Ghadri JR, Templin C. Impact of aspirin on takotsubo syndrome: a propensity score-based analysis of the InterTAK Registry. Eur J Heart Fail. 2020 Feb;22(2):330-337. doi: 10.1002/ejhf.1698. Epub 2019 Dec 20.
Ding KJ, Cammann VL, Szawan KA, Stähli BE, Wischnewsky M, Di Vece D, Citro R, Jaguszewski M, Seifert B, Sarcon A, Knorr M, Heiner S, Gili S, D'Ascenzo F, Neuhaus M, Napp LC, Franke J, Noutsias M, Burgdorf C, Koenig W, Kherad B, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Pott A, Meyer P, Arroja JD, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Paolini C, Bilato C, Carrilho-Ferreira P, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Dichtl W, Chan C, Bridgman P, Delmas C, Lairez O, El-Battrawy I, Akin I, Gilyarova E, Shilova A, Gilyarov M, Kozel M, Tousek P, Widimský P, Winchester DE, Galuszka J, Ukena C, Horowitz JD, Di Mario C, Prasad A, Rihal CS, Pinto FJ, Crea F, Borggrefe M, Braun-Dullaeus RC, Rottbauer W, Bauersachs J, Katus HA, Hasenfuß G, Tschöpe C, Pieske BM, Thiele H, Schunkert H, Böhm M, Felix SB, Münzel T, Bax JJ, Lüscher TF, Ruschitzka F, Ghadri JR, Bossone E, Templin C. Intraventricular Thrombus Formation and Embolism in Takotsubo Syndrome: Insights From the International Takotsubo Registry. Arterioscler Thromb Vasc Biol. 2020 Jan;40(1):279-287. doi: 10.1161/ATVBAHA.119.313491. Epub 2019 Nov 26.
Jurisic S, Gili S, Cammann VL, Kato K, Szawan KA, D'Ascenzo F, Jaguszewski M, Bossone E, Citro R, Sarcon A, Napp LC, Franke J, Noutsias M, Knorr M, Heiner S, Burgdorf C, Koenig W, Pott A, Kherad B, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Meyer P, Arroja JD, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Dworakowski R, Kaiser C, Osswald S, Galiuto L, Dichtl W, Chan C, Bridgman P, Beug D, Delmas C, Lairez O, Kozel M, Tousek P, Winchester DE, Gilyarova E, Shilova A, Gilyarov M, El-Battrawy I, Akin I, Galuszka J, Ukena C, Poglajen G, Paolini C, Bilato C, Carrilho-Ferreira P, Pinto FJ, Opolski G, MacCarthy P, Kobayashi Y, Prasad A, Rihal CS, Widimský P, Horowitz JD, Di Mario C, Crea F, Tschöpe C, Pieske BM, Hasenfuß G, Rottbauer W, Braun-Dullaeus RC, Felix SB, Borggrefe M, Thiele H, Bauersachs J, Katus HA, Schunkert H, Münzel T, Böhm M, Bax JJ, Lüscher TF, Ruschitzka F, Ghadri JR, Templin C. Clinical Predictors and Prognostic Impact of Recovery of Wall Motion Abnormalities in Takotsubo Syndrome: Results From the International Takotsubo Registry. J Am Heart Assoc. 2019 Nov 5;8(21):e011194. doi: 10.1161/JAHA.118.011194. Epub 2019 Nov 1.
Cammann VL, Sarcon A, Ding KJ, Seifert B, Kato K, Di Vece D, Szawan KA, Gili S, Jurisic S, Bacchi B, Micek J, Frangieh AH, Napp LC, Jaguszewski M, Bossone E, Citro R, D'Ascenzo F, Franke J, Noutsias M, Knorr M, Heiner S, Burgdorf C, Koenig W, Thiele H, Tschöpe C, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Dworakowski R, Kaiser C, Osswald S, Galiuto L, Dichtl W, Delmas C, Lairez O, Horowitz JD, Kozel M, Widimský P, Tousek P, Winchester DE, Gilyarova E, Shilova A, Gilyarov M, El-Battrawy I, Akin I, Ukena C, Bauersachs J, Pieske BM, Hasenfuß G, Rottbauer W, Braun-Dullaeus RC, Opolski G, MacCarthy P, Felix SB, Borggrefe M, Di Mario C, Crea F, Katus HA, Schunkert H, Münzel T, Böhm M, Bax JJ, Prasad A, Shinbane J, Lüscher TF, Ruschitzka F, Ghadri JR, Templin C. Clinical Features and Outcomes of Patients With Malignancy and Takotsubo Syndrome: Observations From the International Takotsubo Registry. J Am Heart Assoc. 2019 Aug 6;8(15):e010881. doi: 10.1161/JAHA.118.010881. Epub 2019 Jul 17.
Ghadri JR, Kato K, Cammann VL, Gili S, Jurisic S, Di Vece D, Candreva A, Ding KJ, Micek J, Szawan KA, Bacchi B, Bianchi R, Levinson RA, Wischnewsky M, Seifert B, Schlossbauer SA, Citro R, Bossone E, Münzel T, Knorr M, Heiner S, D'Ascenzo F, Franke J, Sarcon A, Napp LC, Jaguszewski M, Noutsias M, Katus HA, Burgdorf C, Schunkert H, Thiele H, Bauersachs J, Tschöpe C, Pieske BM, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Hasenfuß G, Karakas M, Koenig W, Rottbauer W, Said SM, Braun-Dullaeus RC, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Crea F, Dichtl W, Empen K, Felix SB, Delmas C, Lairez O, El-Battrawy I, Akin I, Borggrefe M, Horowitz J, Kozel M, Tousek P, Widimský P, Gilyarova E, Shilova A, Gilyarov M, Winchester DE, Ukena C, Bax JJ, Prasad A, Böhm M, Lüscher TF, Ruschitzka F, Templin C. Long-Term Prognosis of Patients With Takotsubo Syndrome. J Am Coll Cardiol. 2018 Aug 21;72(8):874-882. doi: 10.1016/j.jacc.2018.06.016.
Templin C, Ghadri JR, Diekmann J, Napp LC, Bataiosu DR, Jaguszewski M, Cammann VL, Sarcon A, Geyer V, Neumann CA, Seifert B, Hellermann J, Schwyzer M, Eisenhardt K, Jenewein J, Franke J, Katus HA, Burgdorf C, Schunkert H, Moeller C, Thiele H, Bauersachs J, Tschöpe C, Schultheiss HP, Laney CA, Rajan L, Michels G, Pfister R, Ukena C, Böhm M, Erbel R, Cuneo A, Kuck KH, Jacobshagen C, Hasenfuss G, Karakas M, Koenig W, Rottbauer W, Said SM, Braun-Dullaeus RC, Cuculi F, Banning A, Fischer TA, Vasankari T, Airaksinen KE, Fijalkowski M, Rynkiewicz A, Pawlak M, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Crea F, Dichtl W, Franz WM, Empen K, Felix SB, Delmas C, Lairez O, Erne P, Bax JJ, Ford I, Ruschitzka F, Prasad A, Lüscher TF. Clinical Features and Outcomes of Takotsubo (Stress) Cardiomyopathy. N Engl J Med. 2015 Sep 3;373(10):929-38. doi: 10.1056/NEJMoa1406761.

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01947621    
Other Study ID Numbers: InterTAK Registry
First Posted: September 20, 2013    Key Record Dates
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:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction