UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051921 |
|---|---|
| Receipt number | R000058692 |
| Scientific Title | Impact of Periodontal Treatment on Clinical Outcomes in Patients with Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Prospective Study (PERIO-PCI) |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/02/15 11:32:23 |
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Basic information
Public title
Impact of Periodontal Treatment on Clinical Outcomes in Patients with Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Acronym
PERIO-PCI
Scientific Title
Impact of Periodontal Treatment on Clinical Outcomes in Patients with Coronary Artery Disease Undergoing Percutaneous Coronary Intervention: A Prospective Study (PERIO-PCI)
Scientific Title:Acronym
PERIO-PCI
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to prospectively examine if periodontal disease treatment can improve clinical outcomes in coronary artery disease patients undergoing percutaneous coronary intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The composite endpoint that includes cardiovascular death, non-fatal myocardial infarction, target lesion revascularization, and non-target lesion revascularization at 24 months
Key secondary outcomes
Inflammatory markers at 12 months (high-sensitivity CRP, IL-6, TNF-alpha)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study will target patients over 20 years of age with coronary artery disease (CAD) who undergo percutaneous catheter intervention (PCI) and who give informed consent to participate in this study. CAD includes stable angina as well as acute coronary syndromes (ACS) which consist of ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina.
Key exclusion criteria
1) Currently undergoing treatment for periodontal disease (PD)
2) Patients with cardiogenic shock, or hemodynamically or electrically unstable acute coronary syndrome (ACS)
3) Positive for COVID-19
4) Currently pregnant or breastfeeding
5) Carrying infectious diseases such as hepatitis virus or HIV.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Taishi |
| Middle name | |
| Last name | Yonetsu |
Organization
Tokyo Medical and Dental University
Division name
Cardiology Division
Zip code
113-8510
Address
1 Chome-5-45 Yushima, Bunkyo City, Tokyo, Japan
TEL
+81-3-3813-6111
t-yonetsu.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Araki |
Organization
Tokyo Medical and Dental University
Division name
Cardiology Division
Zip code
113-8510
Address
1 Chome-5-45 Yushima, Bunkyo City, Tokyo, Japan
TEL
+81-3-3813-6111
Homepage URL
maraki.cvm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
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
Tokyo Medical and Dental University School of Medicine Ethics Review Board
Address
1 Chome-5-45 Yushima, Bunkyo City, Tokyo, Japan
Tel
+81-3-3813-6111
syomu1.adm@tmd.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
| 2023 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | 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
The following observational data collected from electronic medical records will be analyzed:
-Basic information of the research subjects
-General examination results
-Inflammatory markers
-Detail of Percutaneous coronary intervention
-Medications
-Cardiovascular events
-Periodontal disease evaluation
Management information
Registered date
| 2023 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058692
