UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029363 |
|---|---|
| Receipt number | 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 | 2022/04/05 22:23:49 |
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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 | 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
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
s9012@nms.ac.jp
Sponsor or person
Institute
Nippon Medial School Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033021
