UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011128 |
|---|---|
| Receipt number | R000013034 |
| Scientific Title | Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension. |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2016/07/14 08:26:28 |
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Basic information
Public title
Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Acronym
Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Scientific Title
Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Scientific Title:Acronym
Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although phase-resolved 3D phase-contrast MRI allows non-invasive measurement of hemodynamic parameters in patients with pulmonary arterial hypertension in vivo, enough knowledge is not provided. The aim of this study is 1) to measure the flow parameters including flow velocity and wall shear stress by using MRI in the pulmonary artery in patients with PAH. 2) to evaluate the clinical efficacy of these parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic parameters obtained by MRI (arterial flow velocity, wall shear stress)
The occurrence of clinical events
Hemodynamic parameters obtained by right-sided heart catheterization
Hemodynamic parameters obtained by ultrasonic cardiography
6-minute walk distance
Serum BNP level
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pulmonary arterial hypertension
Key exclusion criteria
1) Pulmonary hypertension due to left heart disease.
2) Paced rhythm
3) Pregnant or breast-feeding
4) Inability to obtain informed consent
5) Claustrophobia
6) Contraindication of contrast enhanced MRI
7)Inappropriate patients due to other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Pharmacology & Therapeutics
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
hwat@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Odagiri |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Pharmacology & Therapeutics
Zip code
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL
053-435-2385
Homepage URL
kodagiri@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2013 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.springerplus.com/content/5/1/1071
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
Completed
Date of protocol fixation
| 2007 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
1. To evaluate the relationship between blood flow parameters of pulmonary artery and hemodynamic parameters obtained by right-sided heart catheterization and UCG
2. To evaluate the prognostic value of blood flow parameters
Management information
Registered date
| 2013 | Year | 07 | Month | 05 | Day |
Last modified on
| 2016 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013034
