UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019932 |
|---|---|
| Receipt number | R000023012 |
| Scientific Title | An exploratory research of minute radiation myocardium disorder by the added electrocardiogram device. |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2015/12/15 22:58:07 |
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Basic information
Public title
An exploratory research of minute radiation myocardium disorder by the added electrocardiogram device.
Acronym
An exploratory research of minute radiation myocardium disorder by the added electrocardiogram device.
Scientific Title
An exploratory research of minute radiation myocardium disorder by the added electrocardiogram device.
Scientific Title:Acronym
An exploratory research of minute radiation myocardium disorder by the added electrocardiogram device.
Region
| Japan |
Condition
Condition
several cancers received irradiation to the chest
Classification by specialty
| Cardiology | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to identify minute radiation myocardium disorder by the added electrocardiogram device
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the presence or absence of late potential by the added electrocardiogram before RT(control), just after RT, 3 months after RT, 6 months after RT
1. FQRS-D(Filtered QRS-Duration) more than 114ms
2. RMS40ms(Root-Mean-Square voltage of the signals in the last 40ms) less than 20uV
3. LAS40uV(the duration of the Low-Amplitude Signal after the voltage decreased to less than 40uV) more than 38msec
LP positive means more than 2 items abnormality.
Key secondary outcomes
Echocardiogram; ejection fraction, E/E, TEI index
MRI; late enhancement of ventricular septum
123I-BMIPP; down take of 123I-BMIPP
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
Before RT, just after RT, 3 months after RT, 6 months after RT.
the added electrocardiogram device
echo-cardiogram
MRI(if possible)
123I-BMIPP(if possible)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who received thoracic radiotherapy, and unavoidable cardiac irradiation.
age of 20 to 80 years old at the informed consent
Eastern Cooperative Oncology Group performance status of 0 or 1
over 1 year prognosis
written informed concent
Key exclusion criteria
under 1 year prognosis
skin disease
pacemaker
claustrophobia
drug hypersensitivity
psychiatric disorder
unstable angina and myocardial infarction
not allowing participation into this protocol
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tohru Okada |
Organization
Nagoya University Graduate school of Medicine
Division name
Department of Radiology
Zip code
Address
65 Tsurumai, Syouwa-ku, Nagoya city
TEL
052-744-2328
tohruokada@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Okada |
Organization
Nagoya University Graduate school of Medicine
Division name
Department of Radiology
Zip code
Address
65 Tsurumai, Syouwa-ku, Nagoya city
TEL
052-744-2328
Homepage URL
tohruokada@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate school of Medicine
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
| 2015 | Year | 12 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | 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
| 2015 | Year | 11 | Month | 25 | Day |
Last modified on
| 2015 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023012
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
