UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037403 |
|---|---|
| Receipt number | R000042647 |
| Scientific Title | Retrospective analysis of the prospective cohort of patients with chronic heart failure on atrial fibrillation, cancer and anti-thrombolytic therapy: The CHART-2_Cancer_AF Study |
| Date of disclosure of the study information | 2019/07/17 |
| Last modified on | 2023/11/13 11:53:24 |
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Basic information
Public title
Retrospective analysis of the prospective cohort of patients with chronic heart failure on atrial fibrillation, cancer and anti-thrombolytic therapy: The CHART-2_Cancer_AF Study
Acronym
The CHART-2_Cancer_AF Study
Scientific Title
Retrospective analysis of the prospective cohort of patients with chronic heart failure on atrial fibrillation, cancer and anti-thrombolytic therapy: The CHART-2_Cancer_AF Study
Scientific Title:Acronym
The CHART-2_Cancer_AF Study
Region
| Japan |
Condition
Condition
Patients with chronic heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine incidence of cancer and other clinical outcomes in patients with chronic heart failure and atrial fibrillation with a reference to anti-thrombolytic therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A composite of stroke, systemic thromboembolism and ISTH major bleeding events
Key secondary outcomes
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
1) Structural heart disease but without signs or symptoms of heart failure.
2) Structural heart disease with prior or current symptoms of heart failure.
3) Refractory heart failure requiring specialized interventions.
4) Patients with prior cardiovascular surgery or percutaneous coronary intervention and those who need such interventions.
Key exclusion criteria
None
Target sample size
10219
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Sakata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7153
sakatayk@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Nochioka |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7153
Homepage URL
nochioka@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Daiichi-Sankyo
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Tohoku University Graduate School of Medicine
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 9808574 Japan
Tel
+81-22-717-8007
med-kenkyo@grp.tohoku.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
| 2019 | Year | 07 | Month | 17 | 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
10219
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 07 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042647
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
