UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039988 |
|---|---|
| Receipt number | R000045576 |
| Scientific Title | Impact of coronary physiological assessment for myocardial blood flow and resistance in patients with dilated cardiomyopathy |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/03/31 13:33:10 |
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Basic information
Public title
Impact of coronary physiological assessment for myocardial blood flow and resistance in patients with dilated cardiomyopathy
Acronym
COMBO-DCM study
Scientific Title
Impact of coronary physiological assessment for myocardial blood flow and resistance in patients with dilated cardiomyopathy
Scientific Title:Acronym
COMBO-DCM study
Region
| Japan |
Condition
Condition
Dilated cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between coronary physiological assessment and prognosis in patients with dilated cardiomyopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in left ventricular ejection fraction between baseline and 12 months after coronary physiological assessment
Key secondary outcomes
All-cause mortality, cardiac death, admission for heart failure, cardiac resynchronization therapy, ventricular assist device, heart transplantation
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) Left ventricular dysfunction and dilation (ejection fraction <40% and left ventricular end-diastolic diameter >56mm[male]/>50mm[female] in echocardiography)
2) Indication of cardiac catheterization and coronary physiological assessment
Key exclusion criteria
1) Previous history of admission for heart failure
2) Diagnosis of secondary cardiomyopathy
3) Under transvenous catecholamine injection, cardiac resynchronization therapy or ventricular assist device at cardiac catheterization
4) Coronary stenosis =or>90%
5) Atrial fibrillation at cardiac catheterization
6) Bronchial asthma
7) Severe valvular disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Yonetsu |
Organization
Tokyo Medical and Dental University
Division name
Cardiovascular medicine
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5231
t-yonetsu.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Taishi |
| Middle name | |
| Last name | Yonetsu |
Organization
Tokyo Medical and Dental University
Division name
Cardiovascular medicine
Zip code
1138510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5231
Homepage URL
t-yonetsu.cvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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 Medical and Dental University Institutional Review Board
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
syomu1.adm@tmd.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
| 2020 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of 12-month prognosis after coronary physiological assessment in patients with dilated cardiomyopathy
Management information
Registered date
| 2020 | Year | 03 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045576
