UMIN-CTR Clinical Trial

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 Nobuhisa Middle name Last name Hagiwara
Organization	Tokyo Women's Medical University
Division name	Department of Cardiology
Zip code	1628666
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL	+81333538111
Email	mhagi@hij.twmu.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Jujo
Organization	Tokyo Women's Medical University
Division name	Department of Cardiology
Zip code	1628666
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	Tokyo Women's Medical University Ethics Committee
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
Tel	+81333538111
Email	krinri.bm@twmu.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

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	2017 Year 01 Month 17 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2026 Year 12 Month 31 Day
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	2019 Year 12 Month 25 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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