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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015148
Receipt No. 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

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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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Watanabe
Organization Fujita Health University
Division name Department of Cardiology
Zip code
Address 1-98 Dengakugakubo, Kutukake-cho, Toyoake-shi, Aichi
TEL 0562-93-2312
Email enwatan@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Watanabe
Organization Fujita Health University
Division name Department of Cardiology
Zip code
Address 1-98 Dengakugakubo, Kutukake-cho, Toyoake-shi, Aichi
TEL 0562-93-2312
Homepage URL
Email enwatan@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017531


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