UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048098 |
|---|---|
| Receipt number | R000054793 |
| Scientific Title | Association of Salivary Proline-Rich Proteins With Progression of Atherosclerosis in Patients With Cardiovascular Diseases |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2022/06/30 16:15:51 |
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Basic information
Public title
Association of Salivary Proline-Rich Proteins With Progression of Atherosclerosis in Patients With Cardiovascular Diseases
Acronym
Association of Salivary Proline-Rich Proteins With Progression of Atherosclerosis in Patients With Cardiovascular Diseases
Scientific Title
Association of Salivary Proline-Rich Proteins With Progression of Atherosclerosis in Patients With Cardiovascular Diseases
Scientific Title:Acronym
Association of Salivary Proline-Rich Proteins With Progression of Atherosclerosis in Patients With Cardiovascular Diseases
Region
| Japan |
Condition
Condition
Patients with cardiovascular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find the determinant factors of salivary hPRB1 level based on clinical data at admission in patients with cardiovascular diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between salivary hPRB1 level and clinical data at admission.
Key secondary outcomes
Clinical outcomes (major adverse cardiovascular events, death, cardiovascular death, non-cardiovascular death, myocardial infarction, stent thrombosis, revascularization, cerebrovascular event, heart failure admission, bleeding, acute renal failure, amputation)
Relationship between and salivary hPRB1 concentrations and aortic calcification.
Relationship between salivary hPRB1 concentrations and MAC.
Relationship between salivary hPRB1 concentrations and coronary artery calcification.
Relationship between salivary hPRB1 concentrations and arterial stiffness.
Overall and sub-group analyses stratified by HFpEF, AF, TAVI, PCI, EVT, and ablation for AF.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are hospitalized for cardiovascular diseases
Key exclusion criteria
1. Patients who cannot provide saliva
2. Patients who do not provide informed consent
3. Patients undergoing hemodialysis
4. Patients who are considered inappropriate for the study by the research medical doctor
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Higuchi |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
0263-37-3486
satokoh@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | kanzaki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano, JAPAN
TEL
0263-37-3486
Homepage URL
kanzaki@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano, JAPAN
Tel
0263-37-2572
mdrinri@shinshu-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
| 2022 | Year | 06 | Month | 20 | 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
| 2022 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2022 | Year | 06 | Month | 18 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054793
| 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 |
