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UMIN-CTR Clinical Trial |
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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 | 2019/12/25 |
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 |
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Condition | |||||
Condition | ischemic heart disease | ||||
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 10000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |