UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013230 |
|---|---|
| Receipt number | 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 16:57:40 |
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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
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
tomoaki3est@gmail.com
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015294
| 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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