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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013230
Receipt No. R000015294
Scientific Title Evaluation of chronic obstructive pulmonary disease (COPD) and association between COPD severity and cardiac function at MRI.
Date of disclosure of the study information 2014/02/26
Last modified on 2014/02/23

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Basic information
Public title Evaluation of chronic obstructive pulmonary disease (COPD) and association between COPD severity and cardiac function at MRI.
Acronym Evaluation of COPD at MRI
Scientific Title Evaluation of chronic obstructive pulmonary disease (COPD) and association between COPD severity and cardiac function at MRI.
Scientific Title:Acronym Evaluation of COPD at MRI
Region
Japan

Condition
Condition chronic obstructive pulmonary disease
Classification by specialty
Pneumology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation for the severity of chronic obstructive pulmonary disease using ultra-short echo time magnetic resonance imaging and pulmonary arterial flow measurement in a phase-contrast magnetic resonance angiography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ratio of forced expiratory volume in 1 second to forced vital capacity, percent predicted forced expiratory volume in 1 second, percent low attenuation area, percent wall area ratio, pulmonary T2* value, velocity of the ascending aorta, velocity of the pulmonary artery
Key secondary outcomes

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 A thoracic plain MRI will be performed in addition to a routine chest CT and spirometry examinations.
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 Smoker
Patients suspected of the chronic obstructive pulmonary disease
Patients with the chronic obstructive pulmonary disease
Key exclusion criteria Patients with interstitial pneumonia
Patients with a large lung tumor
Patients with a resected lung lobe
Patients with heart failure
Patients with a pacemaker
Patients contraindicated to MRI
Patients judged as inappropriate by a medical attendant
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Sasaki
Organization Asahikawa Medical University
Division name Radiology
Zip code
Address 2-1-1-1 Midorigaoka-higashi, Asahikawa
TEL +81-166-68-2572
Email tomoaki3est@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomoaki Sasaki
Organization Asahikawa Medical University
Division name Radiology
Zip code
Address 2-1-1-1 Midorigaoka-higashi, Asahikawa
TEL +81-166-68-2572
Homepage URL
Email tomoaki3est@gmail.com

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
2014 Year 02 Month 26 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
2014 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 03 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
2014 Year 02 Month 23 Day
Last modified on
2014 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015294

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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