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
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, see Learn About Clinical Studies.

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:
Takotsubo Cardiomyopathy
Myocardial Infarction
Syndrome
Cardiovascular Diseases
Disease
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases
Ventricular Dysfunction
Ventricular Dysfunction, Left

ClinicalTrials.gov processed this record on October 22, 2014