French Observatory Syndromes Tako-Tsubo (OFSETT)
This study is ongoing, but not recruiting participants.
Sponsor:
French Cardiology Society
Information provided by (Responsible Party):
Jean-Jacques DUJARDIN, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01252004
First received: December 1, 2010
Last updated: June 13, 2012
Last verified: June 2012
| Tracking Information | |||||
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| First Received Date ICMJE | December 1, 2010 | ||||
| Last Updated Date | June 13, 2012 | ||||
| Start Date ICMJE | November 2010 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01252004 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | French Observatory Syndromes Tako-Tsubo | ||||
| Official Title ICMJE | French Observatory Syndromes Tako-Tsubo | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | TT Syndrome
Will be included over a period of one year, prospectively, all patients newly diagnosed |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01252004 | ||||
| Other Study ID Numbers ICMJE | OFSETT | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jean-Jacques DUJARDIN, French Cardiology Society | ||||
| Study Sponsor ICMJE | French Cardiology Society | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | French Cardiology Society | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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