UMIN-CTR Clinical Trial

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 Wataru Middle name Last name shimizu
Organization	Nippon Medial School Hospital
Division name	Department of Cardiology
Zip code	113
Address	1-5,1choume Sendagi Bunkyo-ku Tokyo
TEL	0338222131
Email	wshimizu@nms.ac.jp

Public contact
Name of contact person	1st name Yoichi Middle name Last name Imori
Organization	Nippon Medial School Hospital
Division name	Department of Cardiology
Zip code	113-8603
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	Nippon Medial School Hospital Department of Cardiology medical office
Address	8-29,2 - chome Musashidai Fuchu city, Tokyo
Tel	0338222131
Email	s9012@nms.ac.jp

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	Completed
Date of protocol fixation	2017 Year 08 Month 29 Day
Date of IRB	2017 Year 09 Month 03 Day
Anticipated trial start date	2017 Year 09 Month 04 Day
Last follow-up date	2021 Year 06 Month 25 Day
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	2022 Year 04 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033021