UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041901 |
|---|---|
| Receipt number | R000047825 |
| Scientific Title | The study of cardiovascular complications in osteogenesis imperfecta in adulthood |
| Date of disclosure of the study information | 2020/09/27 |
| Last modified on | 2023/10/18 14:45:22 |
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Basic information
Public title
The study of cardiovascular complications in osteogenesis imperfecta in adulthood
Acronym
The study of cardiovascular complications in osteogenesis imperfecta in adulthood
Scientific Title
The study of cardiovascular complications in osteogenesis imperfecta in adulthood
Scientific Title:Acronym
The study of cardiovascular complications in osteogenesis imperfecta in adulthood
Region
| Japan |
Condition
Condition
osteogenesis imperfecta
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Neurology | Pediatrics | Orthopedics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the frequency of cardiovascular complications in adult patients with osteogenesis imperfecta and contribute to improving patient quality of life.
Basic objectives2
Others
Basic objectives -Others
It is known that osteogenesis imperfecta can be complicated by cardiovascular lesions, but there are few detailed studies. In particular, no studies on cerebral vasculature have existed to date. The purpose of this study is to perform an imaging assessment of cardiovascular issues in patients with osteogenesis imperfecta to determine the prevalence and indications for treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(A) Heart rate and blood pressure
(B) Echocardiography (presence of valvular disease, left ventricular myocardial thickness, left ventricular diameter, left ventricular ejection fraction, aortic valve diameter, Valsalva sinus diameter, ST junction diameter, descending aorta diameter)
(C) Head MRI and MRA (presence of cerebral aneurysm (defined as more than 2 mm) and size). Head MRI includes the evaluation of presence of basilar impression
Key secondary outcomes
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
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients between the ages of 30 and 79 years old who were diagnosed with osteogenesis imperfecta in a medical institution.
Key exclusion criteria
Patients who have received treatment for either cerebrovascular or cardiac disease. Other patients who are deemed by the investigators to be unsuitable as subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Kodama |
Organization
University of Miyazaki Hospital
Division name
Department of pediatrics
Zip code
889-1692
Address
5200 kihara Kiyotake-cho, Miyazaki
TEL
0985-85-0989
kodamayoshihiko@gmail.com
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Kodama |
Organization
University of Miyazaki Hospital
Division name
Department of pediatrics
Zip code
889-1692
Address
5200 kihara Kiyotake-cho, Miyazaki
TEL
0985-85-0989
Homepage URL
kodamayoshihiko@gmail.com
Sponsor or person
Institute
Fukuoka Children's Hospital
AIC Yaesu Clinic
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Network Fukuoka
Address
3-1-1 Maidashi Fukuoka
Tel
092-643-7171
mail@crnfukuoka.jp
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
| 2020 | Year | 09 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolling by invitation
Management information
Registered date
| 2020 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047825
