UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027907 |
|---|---|
| Receipt number | 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 | 2019/12/25 09:09:55 |
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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 | 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
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
juken1123@mac.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
