French Observatory Syndromes Tako-Tsubo

Myocardial Necrosis Clinical Trial

— OFSETT  

Official title:

French Observatory Syndromes Tako-Tsubo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252004
• Other study ID #: OFSETT
• Status: Completed
• Start date: November 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2019
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tako Tsubo syndrome (TTS) is characterized by the occurrence in the context of mental or physical stress, a clinical and ECG of acute myocardial infarction without significant coronary artery stenosis, accompanied by a disorder Acute, reversible left ventricular who takes on a characteristic apical ballonnisation evoking the image of a Japanese octopus trap called Tako (octopus) tsubo (jar). Pathophysiology of unknown changes immediate life-threatening prognosis is often good in the longer term.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18

• allowed for an array of myocardial necrosis on clinical and electro cardiographic

• having a left ventricular ballooning echo cardiography, MRI or ventriculographic with normal coronary angiogram.

Exclusion Criteria:

• Absence of left ventricular ballooning and / or presence of coronary lesions on angiography

• Refusal by the patient to participate in the observatory

Related Conditions & MeSH terms

• Myocardial Infarction
• Myocardial Necrosis
• Necrosis
• Syndrome
• Tako Tsubo Syndromes
• Takotsubo Cardiomyopathy

Locations

Country	Name	City	State
France	CH Douai	Douai

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (8)

Eitel I, Behrendt F, Schindler K, Kivelitz D, Gutberlet M, Schuler G, Thiele H. Differential diagnosis of suspected apical ballooning syndrome using contrast-enhanced magnetic resonance imaging. Eur Heart J. 2008 Nov;29(21):2651-9. doi: 10.1093/eurheartj/ehn433. Epub 2008 Sep 27. — View Citation

El Mahmoud R, Mansencal N, Pilliére R, Leyer F, Abbou N, Michaud P, Nallet O, Digne F, Lacombe P, Cattan S, Dubourg O. Prevalence and characteristics of left ventricular outflow tract obstruction in Tako-Tsubo syndrome. Am Heart J. 2008 Sep;156(3):543-8. doi: 10.1016/j.ahj.2008.05.002. Epub 2008 Jul 7. — View Citation

Gianni M, Dentali F, Grandi AM, Sumner G, Hiralal R, Lonn E. Apical ballooning syndrome or takotsubo cardiomyopathy: a systematic review. Eur Heart J. 2006 Jul;27(13):1523-9. Epub 2006 May 23. Review. — View Citation

Kurisu S, Sato H, Kawagoe T, Ishihara M, Shimatani Y, Nishioka K, Kono Y, Umemura T, Nakamura S. Tako-tsubo-like left ventricular dysfunction with ST-segment elevation: a novel cardiac syndrome mimicking acute myocardial infarction. Am Heart J. 2002 Mar;143(3):448-55. — View Citation

Parodi G, Del Pace S, Carrabba N, Salvadori C, Memisha G, Simonetti I, Antoniucci D, Gensini GF. Incidence, clinical findings, and outcome of women with left ventricular apical ballooning syndrome. Am J Cardiol. 2007 Jan 15;99(2):182-5. Epub 2006 Nov 14. — View Citation

Sharkey SW, Lesser JR, Zenovich AG, Maron MS, Lindberg J, Longe TF, Maron BJ. Acute and reversible cardiomyopathy provoked by stress in women from the United States. Circulation. 2005 Feb 1;111(4):472-9. — View Citation

Tsuchihashi K, Ueshima K, Uchida T, Oh-mura N, Kimura K, Owa M, Yoshiyama M, Miyazaki S, Haze K, Ogawa H, Honda T, Hase M, Kai R, Morii I; Angina Pectoris-Myocardial Infarction Investigations in Japan. Transient left ventricular apical ballooning without coronary artery stenosis: a novel heart syndrome mimicking acute myocardial infarction. Angina Pectoris-Myocardial Infarction Investigations in Japan. J Am Coll Cardiol. 2001 Jul;38(1):11-8. — View Citation

Yayehd K, N'da NW, Belle L, Bataille V, Hanssen M, Leddet P, Aupetit JF, Commeau P, Filippi E, Georges JL, Albert F, Rangé G, Meimoun P, Marcaggi X, Baleynaud S, Nallet O, Dibie A, Barnay C, Jouve B, Legrand M, Cattan S, Mulak G, Simon T, Danchin N, Dujar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological events	Study of psychological events that triggered the event by using the stress scale of the Canadian Association for Mental Health	1 day