UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057608 |
|---|---|
| Receipt number | R000065821 |
| Scientific Title | A study on the establishment of an endothelium-dependent vasodilatory response test as a medical indicator for atherosclerotic vascular disorders with a novel vascular endothelial function measuring device (pFMD). |
| Date of disclosure of the study information | 2025/04/14 |
| Last modified on | 2025/04/14 19:55:36 |
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Basic information
Public title
A study on the establishment of an endothelium-dependent vasodilatory response test as a medical indicator for atherosclerotic vascular disorders with a novel vascular endothelial function measuring device (pFMD).
Acronym
A study on the establishment of an endothelium-dependent vasodilatory response test as a medical indicator for atherosclerotic vascular disorders with a novel vascular endothelial function measuring device (pFMD).
Scientific Title
A study on the establishment of an endothelium-dependent vasodilatory response test as a medical indicator for atherosclerotic vascular disorders with a novel vascular endothelial function measuring device (pFMD).
Scientific Title:Acronym
A study on the establishment of an endothelium-dependent vasodilatory response test as a medical indicator for atherosclerotic vascular disorders with a novel vascular endothelial function measuring device (pFMD).
Region
| Japan |
Condition
Condition
atherosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are (i) to show in a large study that pFMD correlates better with conventional echo-based FMD, (ii) to evaluate the association of pFMD with atherosclerosis risk factors such as age, blood pressure, lipids, blood sugar and lifestyle, and (iii) to determine whether it can be a predictor of cerebrovascular disease in the present study.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to evaluate the association between vascular function and risk factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Infarction (fatal, non-fatal), bleeding in the computer (fatal, non-fatal), subclavian hemorrhage (fatal, non-fatal), recurrence of cardiac tachycardia (PCI, Bappas), infarction of the heart tendon (fatal, non-fatal), cardiac insufficiency (fatal, non-fatal), sudden death, aneurysm of large arteries, dissolution of large arteries (fatal, non-fatal), and occlusive arteries Sclerosis, Devastating neoplasm
Translated with DeepL.com (free version)
Key secondary outcomes
pFMD, FMD, baPWV
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have been seen by a cardiologist for a minimum of 6 months and whose condition is stable. Age 18 years and over.
Key exclusion criteria
(1) Age: under 18
(2) Cases where brachial anthemostasis is not possible
(3) Cases where it is difficult to obtain written explanation and consent
(4) Other cases deemed inappropriate by the physician
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Yukihito |
| Middle name | |
| Last name | Higashi |
Organization
Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name
Department of Regenerative Medicine, Division of Radiation Medical Science
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
81-82-257-5831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Kishimoto |
Organization
Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name
Department of Regenerative Medicine, Division of Radiation Medical Science
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
81-82-257-5831
Homepage URL
skishimoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
no funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Ethics Review Committee
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
082-257-5947
iryo-sinsa@office.hiroshima-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 14 | 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
| 2025 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data for the study are from medical records and include vascular function (pFMD, FMD, NID, PWV, brachial artery IMT, vessel diameter), age, sex, height, weight, BMI, abdominal circumference, blood pressure, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, HbA1c, blood sugar, creatinine, urea nitrogen , uric acid, CRP, uric acid level, Na, K, Cl, AST, ALT, WBC, RBC, Plt, Hb, Hct, urinary albumin, urinary creatinine, urinary Na, urinary K, IgG4, small dense LDL, oxidised LDL, Framingham risk score, medical history (hypertension, hyperlipidaemia, diabetes, brain vascular disease, cardiovascular disease, heart failure, arteriosclerosis obliterans, arrhythmias, malignant neoplasms), medications (diabetes medications, antihypertensive medications, dyslipidaemia medications, cardiovascular disease medications and others), lifestyle habits (smoking, alcohol consumption, exercise habits) and event information.
Management information
Registered date
| 2025 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065821
