UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief 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.
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hiroshi Watanabe
Organization	Hamamatsu University School of Medicine
Division name	Clinical Pharmacology & Therapeutics
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Email	hwat@hama-med.ac.jp

Public contact
Name of contact person	Keiichi Odagiri
Organization	Hamamatsu University School of Medicine
Division name	Clinical Pharmacology & Therapeutics
Address	1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Homepage URL
Email	kodagiri@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.springerplus.com/content/5/1/1071
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013034