French Observatory Syndromes Tako-Tsubo (OFSETT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean-Jacques DUJARDIN, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01252004
First received: December 1, 2010
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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
Myocardial Necrosis
Tako Tsubo Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: French Observatory Syndromes Tako-Tsubo

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Psychological events [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Study of psychological events that triggered the event by using the stress scale of the Canadian Association for Mental Health


Enrollment: 121
Study Start Date: November 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
TT Syndrome
Will be included over a period of one year, prospectively, all patients newly diagnosed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252004

Locations
France
CH Douai
Douai, France
Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Jean-Jacques Dujardin AP-HP
  More Information

Publications:

Responsible Party: Jean-Jacques DUJARDIN, Professor, French Cardiology Society
ClinicalTrials.gov Identifier: NCT01252004     History of Changes
Other Study ID Numbers: OFSETT
Study First Received: December 1, 2010
Last Updated: September 27, 2013
Health Authority: France : CNIL

Keywords provided by French Cardiology Society:
Left ventricular ballooning

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

ClinicalTrials.gov processed this record on April 17, 2014