Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-29 @ 7:31 PM
Study NCT ID:
NCT01252004
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2010-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Observatory Syndromes Tako-Tsubo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D054549', 'term': 'Takotsubo Cardiomyopathy'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2010-12-01', 'studyFirstSubmitQcDate': '2010-12-01', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological events', 'timeFrame': '1 day', 'description': 'Study of psychological events that triggered the event by using the stress scale of the Canadian Association for Mental Health'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Left ventricular ballooning'], 'conditions': ['Myocardial Necrosis', 'Tako Tsubo Syndromes']}, 'referencesModule': {'references': [{'pmid': '11868050', 'type': 'BACKGROUND', '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. doi: 10.1067/mhj.2002.120403.'}, {'pmid': '11451258', 'type': 'BACKGROUND', '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. doi: 10.1016/s0735-1097(01)01316-x.'}, {'pmid': '15687136', 'type': 'BACKGROUND', '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. doi: 10.1161/01.CIR.0000153801.51470.EB.'}, {'pmid': '17223415', 'type': 'BACKGROUND', '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. doi: 10.1016/j.amjcard.2006.07.080. Epub 2006 Nov 14.'}, {'pmid': '16720686', 'type': 'BACKGROUND', '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. doi: 10.1093/eurheartj/ehl032. Epub 2006 May 23.'}, {'pmid': '18760139', 'type': 'BACKGROUND', 'citation': 'El Mahmoud R, Mansencal N, Pilliere 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.'}, {'pmid': '18820322', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26507532', 'type': 'RESULT', 'citation': "Yayehd K, N'da NW, Belle L, Bataille V, Hanssen M, Leddet P, Aupetit JF, Commeau P, Filippi E, Georges JL, Albert F, Range 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, Dujardin JJ; OFSETT investigators. Management of Takotsubo cardiomyopathy in non-academic hospitals in France: The Observational French SyndromEs of TakoTsubo (OFSETT) study. Arch Cardiovasc Dis. 2016 Jan;109(1):4-12. doi: 10.1016/j.acvd.2015.08.004. Epub 2015 Oct 23."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients newly diagnosed for a Tako-Tsubo Syndrome. Recruitment will be from the centers of coronary angiography and coronary angioplasty in high volume.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18\n* allowed for an array of myocardial necrosis on clinical and electro cardiographic\n* having a left ventricular ballooning echo cardiography, MRI or ventriculographic with normal coronary angiogram.\n\nExclusion Criteria:\n\n* Absence of left ventricular ballooning and / or presence of coronary lesions on angiography\n* Refusal by the patient to participate in the observatory'}, 'identificationModule': {'nctId': 'NCT01252004', 'acronym': 'OFSETT', 'briefTitle': 'French Observatory Syndromes Tako-Tsubo', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'French Observatory Syndromes Tako-Tsubo', 'orgStudyIdInfo': {'id': 'OFSETT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TT Syndrome', 'description': 'Will be included over a period of one year, prospectively, all patients newly diagnosed'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Douai', 'country': 'France', 'facility': 'CH Douai', 'geoPoint': {'lat': 50.37069, 'lon': 3.07922}}], 'overallOfficials': [{'name': 'Jean-Jacques Dujardin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean-Jacques DUJARDIN', 'investigatorAffiliation': 'French Cardiology Society'}}}}