UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027960 |
|---|---|
| Receipt number | R000028053 |
| Scientific Title | Therapy evaluation by phase-contrast MRI for pulmonary hypertension: Multicenter prospective exploratory study |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2021/01/07 21:14:31 |
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Basic information
Public title
Therapy evaluation by phase-contrast MRI for pulmonary hypertension: Multicenter prospective exploratory study
Acronym
Therapy evaluation by PCMRI for PH
Scientific Title
Therapy evaluation by phase-contrast MRI for pulmonary hypertension: Multicenter prospective exploratory study
Scientific Title:Acronym
Therapy evaluation by PCMRI for PH
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether PC-MRI is useful for an index of the effect of treatment for the patient with pulmonary arterial hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of pulmonary flow measured by PC-MRI in the before and after therapy
Key secondary outcomes
The change of the measurement values of PC-MRI:Mean velocity, Acceleration time, Peak velocity, maximal change in the flow rate/Acceleration volume, Cardiac index
Correlation between pulmonary flow and mean pulmonary arterial pressure and 6 minutes distance walk.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We perform MR exam two times of plans before and 3-6 months after therapy.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The patients to perform pharmacotherapy with the vasodilator in for pulmonary hypertension in hospital attached to the University of Ryukyu School of Medicine, Kanagawa circulatory organ respiratory disease center, Sapporo Medical College hospital during a period with December, 2018 from December, 2016.
2.Written informed consent is obtained.
Key exclusion criteria
1.MRI contraindication, relative contraindicated matter pertinence person (claustrophobia, the pregnant woman, the patients implanted metal in the body, the patients with the tattoo)
2.The patients who cannot keep rest 30 minutes or more with a dorsal position
3.Chronic thromboembolic pulmonary hypertension
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sadayuki |
| Middle name | |
| Last name | Murayama |
Organization
Graduate School of Medical Science, University of the Ryukyus
Division name
Department of Radiology
Zip code
9030215
Address
207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL
098-895-1162
sadayuki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Jyunji |
Organization
Graduate School of Medical Science, University of the Ryukyus
Division name
Department of Radiology
Zip code
9030215
Address
207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL
098-895-1162
Homepage URL
es4d8yd@gmail.com
Sponsor or person
Institute
Graduate School of Medical Science, University of the Ryukyus
Department of Radiology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Graduate School of Medical Science, University of the Ryukyus
Address
207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
Tel
0988951162
sadayuki@med.u-ryukyu.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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was terminated because it was found that a sufficient number of cases were not expected to collect.
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028053
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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