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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048098
Receipt No. 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

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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
Email 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
Email kanzaki@shinshu-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Shinshu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054793

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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