UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027960
Receipt No. 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 2018/01/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Sadayuki Murayama
Organization Graduate School of Medical Science, University of the Ryukyus
Division name Department of Radiology
Zip code
Address 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL 098-895-1162
Email sadayuki@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jyunji Ito
Organization Graduate School of Medical Science, University of the Ryukyus
Division name Department of Radiology
Zip code
Address 207 Uehara, Nishihara-cho, Nakagami-gun, Okinawa, Japan
TEL 098-895-1162
Homepage URL
Email es4d8yd@gmail.com

Sponsor
Institute Graduate School of Medical Science, University of the Ryukyus
Department of Radiology
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 28 Day
Last modified on
2018 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.