UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015189 |
|---|---|
| Receipt number | R000017605 |
| Scientific Title | Research on the Correction Method of Electrocardiographic QT Interval in Relation to Heart Rate: Study on Optimal Conditions for the Adoption of Data with Increased Heart Rate by Exercise |
| Date of disclosure of the study information | 2014/09/17 |
| Last modified on | 2014/09/24 16:16:47 |
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Basic information
Public title
Research on the Correction Method of Electrocardiographic QT Interval in Relation to Heart Rate:
Study on Optimal Conditions for the Adoption of Data with Increased Heart Rate by Exercise
Acronym
QT-LT
Scientific Title
Research on the Correction Method of Electrocardiographic QT Interval in Relation to Heart Rate:
Study on Optimal Conditions for the Adoption of Data with Increased Heart Rate by Exercise
Scientific Title:Acronym
QT-LT
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the RR-QT relationship using ECG data in a resting state and during increased heart rates in adult subjects and the appropriate data for TQTs.
Basic objectives2
Others
Basic objectives -Others
To examine best method of exercise load
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Coeffient of determination between QT and RR interval
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Tredmill exercise load
Interventions/Control_2
Master double two-step exercise load
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Subjects, Japanese male, are between 20 and 40 years old at the time of Informed Consent
2. Subjects must be 17.6-26.4kg/m2 in BMI
3. Subject must be judged eligible for inclusion in the study by the investigator after examining the investigator's interview, a subjective symptom, physical and laboratory test
Key exclusion criteria
1. A person who take some medicine, except local administration, within 7 days before hospitalization
2. A person who have risk factors of Trsade de Pointes, cardiac insufficiency, hypokalemia, QT-prolongation syndrome, etc
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Kumagai |
Organization
Kitasato University East Hospital
Division name
Clinical Trial Center
Zip code
Address
2-1-1, Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan
TEL
042-748-9111
kuma-guy@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Sakamoto |
Organization
Kitasato University
Division name
Clinical Research Center
Zip code
Address
1-15-1, Kitasato, Minami, Sagamihara, Kanagawa, 252-0374 Japan
TEL
042-778-9547
Homepage URL
kcrcinfo@med.kitasato-u.ac.jp
Sponsor or person
Institute
Clinical Trial Center, Kitasato University East Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
| 2014 | Year | 09 | Month | 17 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 03 | 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 | 09 | Month | 17 | Day |
Last modified on
| 2014 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017605
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
