UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015148 |
|---|---|
| Receipt number | R000017531 |
| Scientific Title | Prognostic significance of Holter-derived T wave variability in patients with acute coronary syndrome |
| Date of disclosure of the study information | 2014/09/16 |
| Last modified on | 2019/09/17 16:43:55 |
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Basic information
Public title
Prognostic significance of Holter-derived T wave variability in patients with acute coronary syndrome
Acronym
TWIST study
Scientific Title
Prognostic significance of Holter-derived T wave variability in patients with acute coronary syndrome
Scientific Title:Acronym
TWIST study
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intended for acute coronary syndrome patients who had undergone coronary reperfusion therapy and take agents that confirm to the guidelines, and to develop a prognostic indicator by electrocardiographic information obtained from high-resolution digital Holter electrocardiogram (ELA medical, France).
Basic objectives2
Others
Basic objectives -Others
Development of the prognostic indicators
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
All cause death
Key secondary outcomes
Cardiovascular death (acute MI, stroke, aortic dissection, systemic emobolism, sudden death), hospitalization due to worsening heart failure, revascularization, lethal arrhythmia, detection new-onset atrial fibrillation, implantation of the defibrillator or pacemaker)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Coronary reperfusion therapy has been performed on the acute coronary syndrome.
- Patients who takes renin-angiotensin system inhibitors and beta-blockers.
- No history of cardiovascular serious accident(myocardial infarction, stroke, catheter treatment or cardiovascular surgery) in the past three months.
- Consent for the study was obtained.
Key exclusion criteria
- Patients suffering from malignant disease that is active.
- Patients who has pregnancy, breastfeeding or suspected of being pregnant.
- Patients who do not obtain written consent.
- Pacemaker has been implanted for the treatment of bradyarrhythmias.
- If the attending physician has determined ineligible as an object of this study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Watanabe |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1101
Address
1-98 Dengakugakubo, Kutukake-cho, Toyoake-shi, Aichi
TEL
0562-93-2312
enwatan@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Watanabe |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1101
Address
1-98 Dengakugakubo, Kutukake-cho, Toyoake-shi, Aichi
TEL
0562-93-2312
Homepage URL
enwatan@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Suzuken Memorial Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
Tel
0562-93-2865
enwatan@fujita-hu.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
東海大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To implement the prognosis investigation after two years and one year later.
Management information
Registered date
| 2014 | Year | 09 | Month | 13 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017531
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
