UMIN-CTR Clinical Trial

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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