UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043405 |
|---|---|
| Receipt number | R000049514 |
| Scientific Title | Prospective study of the association between changes in Cardio-Ankle Vascular Index (CAVI) and cardiac structure and function assessed using cardiovascular magnetic resonance (CMR) parameters |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/03/03 11:28:53 |
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Basic information
Public title
Prospective study of the association between changes in Cardio-Ankle Vascular Index (CAVI) and cardiac structure and function assessed using cardiovascular magnetic resonance (CMR) parameters.
Acronym
Changes in CAVI and cardiac structure and function assessed using CMR.
Scientific Title
Prospective study of the association between changes in Cardio-Ankle Vascular Index (CAVI) and cardiac structure and function assessed using cardiovascular magnetic resonance (CMR) parameters
Scientific Title:Acronym
Changes in CAVI and cardiac structure and function assessed using CMR.
Region
| Japan |
Condition
Condition
Patients with hypertension, diabetes, hyperlipidemia, renal dysfunction, atrial fibrillation, sleep apnea syndrome, chronic obstructive pulmonary disease, hyperuricemia, current smoking habit, or a history of cardiovascular events.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed
1) To investigate the association between the changes in CAVI and cardiac structure and function evaluated by CMR parameters.
2) To investigate the association between CMR parameters and various parameters; CAVI, ECG, NT-proBNP[Blood Sampling], and blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The association between the change in CAVI and the change in CMR parameters.
Key secondary outcomes
The association between
1) CMR parameters and ECG, Blood Pressure, and NT-proBNP
2) Onset of Major cardiovascular events and each parameter measured in this study.
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
To undergo the following examinations;
1)CAVI, ECG (baseline and once a year)
2)CMR, NT-proBNP (baseline and 1, 3 years later).
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
Patients with at least one of the following risk factor of cardiovascular event:
hypertension, diabetes, hyperlipidemia, renal dysfunction, atrial fibrillation, sleep apnea syndrome, chronic obstructive pulmonary disease, hyperuricemia,
current smoking habit, a history of cardiovascular events.
Key exclusion criteria
Patients who are considered not eligible for this study by the investigators.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of cardiovascular medicine, Department of medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
TEL
0285-58-7344
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of cardiovascular medicine, Department of medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
TEL
0285-58-7344
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Division of cardiovascular medicine, Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Community Medicine Cardiovascular
Research Asia IT Network Center,
Division of Cardiovascular Medicine
Jichi Medical University School of
Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
FUKUDA DENSHI CO.,LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University School of Medicine
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
Tel
0285-58-8933
rinri@jichi.ac.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
鷲谷病院(栃木県) Washiya Hospital, Utsunomiya-shi, Tochigi, JAPAN
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | 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
| 2021 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 22 | Day |
Last modified on
| 2021 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049514
