French Observatory Syndromes Tako-Tsubo (OFSETT)

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. Read our disclaimer for details. Identifier: NCT01252004
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Jean-Jacques DUJARDIN, French Cardiology Society

Brief 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.

Condition or disease
Myocardial Necrosis Tako Tsubo Syndromes

Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: French Observatory Syndromes Tako-Tsubo
Study Start Date : November 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

TT Syndrome
Will be included over a period of one year, prospectively, all patients newly diagnosed

Primary Outcome Measures :
  1. Psychological events [ Time Frame: 1 day ]
    Study of psychological events that triggered the event by using the stress scale of the Canadian Association for Mental Health

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly diagnosed for a Tako-Tsubo Syndrome. Recruitment will be from the centers of coronary angiography and coronary angioplasty in high volume.

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

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 identifier (NCT number): NCT01252004

CH Douai
Douai, France
Sponsors and Collaborators
French Cardiology Society
Principal Investigator: Jean-Jacques Dujardin Assistance Publique - Hôpitaux de Paris

Publications of Results:
Other Publications:

Responsible Party: Jean-Jacques DUJARDIN, Professor, French Cardiology Society Identifier: NCT01252004     History of Changes
Other Study ID Numbers: OFSETT
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Jean-Jacques DUJARDIN, French Cardiology Society:
Left ventricular ballooning

Additional relevant MeSH terms:
Myocardial Infarction
Takotsubo Cardiomyopathy
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction