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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029363
Receipt No. R000033021
Scientific Title Registry for Evaluation of Cardiac function and Outcomes after VEntriculaR dysfunction of TakoTsubo Syndrome
Date of disclosure of the study information 2017/10/01
Last modified on 2017/10/01

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Basic information
Public title Registry for Evaluation of Cardiac function and Outcomes after VEntriculaR dysfunction of TakoTsubo Syndrome
Acronym RECOVER-TTS
Scientific Title Registry for Evaluation of Cardiac function and Outcomes after VEntriculaR dysfunction of TakoTsubo Syndrome
Scientific Title:Acronym RECOVER-TTS
Region
Japan

Condition
Condition Takotsubo Syndrome
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate patient characteristics, and cardiac function, and prognosis of patients with of Takotsubo syndrome.
Basic objectives2 Others
Basic objectives -Others Clinical research
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiac function assessed by echocardiography and cardiac magnetic resonance at one year follow up
Key secondary outcomes 1.Composite endpoint of death from any cause, life-threatening arrhythmia, readmission due to any cause, recurrence of Takotsubo syndrome, and stroke within 1 year, and its single components

2. In-hospital composite endpoint of death from any cause, life threatening arrhythmia, shock, the use of invasive or noninvasive ventilation, and stroke, and its single components

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. The presence of a transient abnormality in left ventricular wall motion beyond a single epicardial coronary artery perfusion territory
2. The absence of obstructive coronary artery disease or evidence of acute plaque rupture in coronary in angiography or coronary computed tomography
3. The presence of new electrocardiographic abnormalities or elevation in cardiac troponin levels
4. The absence of myocarditisExceptions to these criteria are the focal (within one coronary distribution) type and death during the acute phase before wall-motion recovery in a patient matching all other criteria.
If coronary disease is found, the diagnosis of stress cardiomyopathy can still be made if the wall motion abnormalities are not in the distribution of the coronary disease.
In patients with phaeochromocytoma, the pathophysiology and clinical phenotype are identical and hence the consensus of the authors is to include patients with this condition.
The diagnosis of a transient abnormality in left ventricular wall motion due to vasospastic angina
Key exclusion criteria The diagnosis of a transient abnormality in left ventricular wall motion due to vasospastic angina
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru shimizu
Organization Nippon Medial School Hospital
Division name Department of Cardiology
Zip code
Address 1-5,1choume Sendagi Bunkyo-ku Tokyo
TEL 0338222131
Email wshimizu@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Imori
Organization Nippon Medial School Hospital
Division name Department of Cardiology
Zip code
Address 1-5,1choume Sendagi Bunkyo-ku Tokyo
TEL 0338222131
Homepage URL
Email s9012@nms.ac.jp

Sponsor
Institute Nippon Medial School Hospital
Institute
Department

Funding Source
Organization Nippon Medial School Hospital Department of Cardiology medical office
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学附属病院(千葉県)、東海大学医学部附属病院(神奈川県)、武蔵野赤十字病院(東京都)、東京都立多摩総合医療センター(東京都)、榊原記念病院(東京都)、聖路加国際病院(東京都)、君津中央病院(千葉県)、千葉県救急医療センター(千葉県)、聖マリアンナ医科大学(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2017 Year 10 Month 01 Day
Last modified on
2017 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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