Clinical trial NCT01947621: International Takotsubo Registry (InterTAK Registry)
Official title: International Multicenter Registry on Takotsubo Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Takotsubo Cardiomyopathy
Keywords: Broken heart syndrome, stress cardiomyopathy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of California, Davis
name: Hannover Medical School
name: Ludwig-Maximilians - University of Munich
name: University of Heidelberg Medical Center
name: University Hospital Schleswig-Holstein
name: Charite University, Berlin, Germany
name: University of Kentucky
name: Medical University of Cologne
name: University Hospital, Saarland
name: University Hospital, Essen
name: Asklepios Kliniken Hamburg GmbH
name: University Hospital Goettingen
name: University of Magdeburg
name: Oxford University Hospitals NHS Trust
name: Kantonsspital Winterthur KSW
name: Turku University Hospital
name: Medical University of Gdansk
name: Medical University of Warsaw
name: University Hospital, Basel, Switzerland
name: Catholic University of the Sacred Heart
name: Medical University Innsbruck
name: Cardiocentro Ticino
name: Luzerner Kantonsspital
name: Mayo Clinic
First posted: 2013-09-20
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with manifest 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).

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

Primary outcomes:
measure: Natural history of TTC
timeFrame: 10 years
Secondary outcomes:
measure: Cardiovascular complications, recurrence of TTC and all cause mortality
timeFrame: at hospitalizsation, short term (1 year) and long term (10 years)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Cardiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Cardiology
name: Christian Templin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cammann VL, Scheitz JF, von Rennenberg R, Jancke L, Nolte CH, Szawan KA, Stengl H, Wurdinger M, Endres M, Templin C, Ghadri JR; InterTAK Consortium. Clinical correlates and prognostic impact of neurologic disorders in Takotsubo syndrome. Sci Rep. 2021 Dec 7;11(1):23555. doi: 10.1038/s41598-021-01496-9.
citation: El-Battrawy I, Cammann VL, Kato K, Szawan KA, Di Vece D, Rossi A, Wischnewsky M, Hermes-Laufer J, Gili S, Citro R, Bossone E, Neuhaus M, Franke J, Meder B, Jaguszewski M, Noutsias M, Knorr M, Heiner S, D'Ascenzo F, Dichtl W, Burgdorf C, Kherad B, Tschope C, Sarcon A, Shinbane J, Rajan L, Michels G, Pfister R, Cuneo A, Jacobshagen C, Karakas M, Koenig W, Pott A, Meyer P, David Arroja J, Banning A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Napp LC, Budnik M, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Chan C, Bridgman P, Beug D, Delmas C, Lairez O, Gilyarova E, Shilova A, Gilyarov M, Kozel M, Tousek P, Winchester DE, Galuszka J, Ukena C, Poglajen G, Carrilho-Ferreira P, Hauck C, Paolini C, Bilato C, Kobayashi Y, Prasad A, Rihal CS, Liu K, Schulze PC, Bianco M, Jorg L, Rickli H, Pestana G, Nguyen TH, Bohm M, Maier LS, Pinto FJ, Widimsky P, Felix SB, Opolski G, Braun-Dullaeus RC, Rottbauer W, Hasenfuss G, Pieske BM, Schunkert H, Thiele H, Bauersachs J, Katus HA, Horowitz JD, Di Mario C, Munzel T, Crea F, Bax JJ, Luscher TF, Ruschitzka F, Duru F, Borggrefe M, Ghadri JR, Akin I, Templin C. Impact of Atrial Fibrillation on Outcome in Takotsubo Syndrome: Data From the International Takotsubo Registry. J Am Heart Assoc. 2021 Aug 3;10(15):e014059. doi: 10.1161/JAHA.119.014059. Epub 2021 Jul 28.
citation: Cammann VL, Sarcon A, Szawan KA, Wurdinger M, Azam S, Shinbane J, Seifert B, Ghadri JR, Saw J, Templin C. Clinical characteristics and outcomes of patients with takotsubo syndrome versus spontaneous coronary artery dissection. Cardiol J. 2023;30(1):125-130. doi: 10.5603/CJ.a2021.0065. Epub 2021 Jun 24.
citation: Imori Y, Kato K, Cammann VL, Szawan KA, Wischnewsky M, Dreiding S, Wurdinger M, Schonberger M, Petkova V, Niederseer D, Levinson RA, Di Vece D, Gili S, Seifert B, Wakita M, Suzuki N, Citro R, Bossone E, Heiner S, Knorr M, Jansen T, Munzel T, D'Ascenzo F, Franke J, Sorici-Barb I, Katus HA, Sarcon A, Shinbane J, Napp LC, Bauersachs J, Jaguszewski M, Shiomura R, Nakamura S, Takano H, Noutsias M, Burgdorf C, Ishibashi I, Himi T, Koenig W, Schunkert H, Thiele H, Kherad B, Tschope C, Pieske BM, Rajan L, Michels G, Pfister R, Mizuno S, Cuneo A, Jacobshagen C, Hasenfuss G, Karakas M, Mochizuki H, Pott A, Rottbauer W, Said SM, Braun-Dullaeus RC, Banning A, Isogai T, Kimura A, Cuculi F, Kobza R, Fischer TA, Vasankari T, Airaksinen KEJ, Tomita Y, Budnik M, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Crea F, Dichtl W, Murakami T, Ikari Y, Empen K, Beug D, Felix SB, Delmas C, Lairez O, Yamaguchi T, El-Battrawy I, Akin I, Borggrefe M, Horowitz JD, Kozel M, Tousek P, Widimsky P, Gilyarova E, Shilova A, Gilyarov M, Neuhaus M, Meyer P, Arroja JD, Chan C, Bridgman P, Galuszka J, Poglajen G, Carrilho-Ferreira P, Pinto FJ, Hauck C, Maier LS, Liu K, Di Mario C, Paolini C, Bilato C, Bianco M, Jorg L, Rickli H, Winchester DE, Ukena C, Bohm M, Bax JJ, Prasad A, Rihal CS, Saito S, Kobayashi Y, Luscher TF, Ruschitzka F, Shimizu W, Ghadri JR, Templin C. Ethnic comparison in takotsubo syndrome: novel insights from the International Takotsubo Registry. Clin Res Cardiol. 2022 Feb;111(2):186-196. doi: 10.1007/s00392-021-01857-4. Epub 2021 May 19.
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citation: 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, Munzel T, Knorr M, Heiner S, Katus HA, Burgdorf C, Schunkert H, Thiele H, Bauersachs J, Tschope 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, Widimsky P, Gilyarova E, Shilova A, Gilyarov M, Biondi-Zoccai G, Winchester DE, Ukena C, Neuhaus M, Bax JJ, Prasad A, Di Mario C, Bohm M, Gasparini M, Ruschitzka F, Bossone E, Citro R, Rinaldi M, De Ferrari GM, Luscher 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.
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