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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027907
Receipt No. R000031956
Scientific Title Multi-center prospective registry of patients with ischemic heart disease after percutaneous coronary intervention in Tokyo Women's Medical University (TMWU)-related hospitals
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/23

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Basic information
Public title Multi-center prospective registry of patients with ischemic heart disease after percutaneous coronary intervention in Tokyo Women's Medical University (TMWU)-related hospitals
Acronym Tokyo Women's medical university INterhospital Connections REgistry (TWINCRE)
Scientific Title Multi-center prospective registry of patients with ischemic heart disease after percutaneous coronary intervention in Tokyo Women's Medical University (TMWU)-related hospitals
Scientific Title:Acronym Tokyo Women's medical university INterhospital Connections REgistry (TWINCRE)
Region
Japan

Condition
Condition ischemic heart disease
Classification by specialty
Medicine in general Cardiology Neurology
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate clinical outcomes after percutaneous coronary intervention, and clarify risk factors relating adverse events
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MACCE (Major adverse cardio- and cerebro-vascular event)
Key secondary outcomes 1. death from any cause
2. target vessel revascularizaiton
3. stent thrombosis
4. quality of life (QOL), depression
5. complications: catheter procedure-related/non-related

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 patient who was treated with percutaneous coronary intervention (PCI) and produced written informed consent in Tokyo Women's Medical University or University-related hospitals.
Indication for PCI is in accordance with guidelines.
Key exclusion criteria 1. patients who have intolerance of anti-platelets or anticoagulants scheduled to use
2. patients with severe allergic reactions against iodinated contrast
3. patients whose life expectancy of less than 12 months due to non-cardiac conditions at the enrollment
4. patients who are pregnant or during breast-feeding
5. patients who are regarded as ineligible for PCI at the conference with cardiac surgeons
6. inadequate patient judged by principal investigator
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhisa Hagiwara
Organization Tokyo Women's Medical University
Division name Department of Cardiology
Zip code
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL +81333538111
Email mhagi@hij.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Jujo
Organization Tokyo Women's Medical University
Division name Department of Cardiology
Zip code
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo
TEL +81333538111
Homepage URL
Email juken1123@mac.com

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Registration has sequentially started in 13 participating institutions

Management information
Registered date
2017 Year 06 Month 23 Day
Last modified on
2017 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031956

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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