UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009386 |
|---|---|
| Receipt number | R000010974 |
| Scientific Title | Comprehensive risk assessment by cardiac MRI and PET in patients with diastolic heart failure |
| Date of disclosure of the study information | 2012/11/22 |
| Last modified on | 2019/10/29 12:52:10 |
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Basic information
Public title
Comprehensive risk assessment by cardiac MRI and PET in patients with diastolic heart failure
Acronym
Comprehensive risk assessment by cardiac MRI and PET
Scientific Title
Comprehensive risk assessment by cardiac MRI and PET in patients with diastolic heart failure
Scientific Title:Acronym
Comprehensive risk assessment by cardiac MRI and PET
Region
| Japan |
Condition
Condition
Chronic heart failure with LVEF more than and equal 40%
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To develop the model for the evaluation of cardiac risk by using cardiac MRI-meausred diastolic function, coronary flow reserve, and scar, and PET-measured sympathetic function.
2) to evaluate the mechanism of diastolic dysfunctio and to develop the effective therapy for each patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. patient's characteristics
2. Symptom
3. Patient's history
4. Cardiac history
5. History of heart failure
6. Clinical variables
7. Echocardiography
8. Cardiac MRI
9. Cardiac PET
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
Patients
1. Age more than and equal 20 yo.
2. Chronic heart failure diagnosed by Framingham criteria
3. LVEF more than and equal 40%
4. Patients who agree with informed consent
Healty controls
1. Age more than and equal 20yo.
2. No heart failure symptom
3. Subjects who agree with informed consent
Key exclusion criteria
Patients
1. Chronic kidney disease (eGFR<30 mL/min2)
2. Claustrophobia
Healty controls
1. Chronic kidney disease (eGFR<30 mL/min2)
2. Claustrophobia
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tsutsui |
Organization
Hokkaido University Guraduate School of Medicine
Division name
Cardiovasculer Medicine
Zip code
060-8638
Address
kita 15 jyo, nisi 7 chome ,kitaku,Sapporo,Hokkaido
TEL
011-706-6073
naya@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masanao |
| Middle name | |
| Last name | Naya |
Organization
Hokkaido University Guraduate School of Medicine
Division name
Cardiovasculer Medicine
Zip code
060-8638
Address
Kitty 15, West 7, Kitaku, Sapporo
TEL
011-706-6973
Homepage URL
nayamasanao@yahoo.co.jp
Sponsor or person
Institute
Hokkaido University Guraduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKEN
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
North 15, West 5, Kitaku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2012 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
noe
Publication of results
Published
Result
URL related to results and publications
J Nucl Med. 2017 May;58(5):784-790. doi: 10.2967/jnumed.116.178558.
Number of participants that the trial has enrolled
53
Results
Please see a paper above
Results date posted
| 2019 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please see a paper above
Participant flow
Please see a paper above
Adverse events
none
Outcome measures
Please see a paper above
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2012 | Year | 11 | Month | 22 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010974
| Research Plan | |
|---|---|
| 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 |
