UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038606
Receipt number R000044000
Scientific Title The Relationship between Periodontitis and Atherosclerosis in Patients with Acute Coronary Syndrome and The Impact for Periodontal Treatment to Atherosclerosis: A Prospective Observational Study
Date of disclosure of the study information 2019/11/18
Last modified on 2023/05/22 13:05:20

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Basic information

Public title

The Relationship between Periodontitis and Atherosclerosis in Patients with Acute Coronary Syndrome and The Impact for Periodontal Treatment to Atherosclerosis: A Prospective Observational Study

Acronym

The Relationship between Periodontitis and Atherosclerosis in Patients with Acute Coronary Syndrome and The Impact for Periodontal Treatment to Atherosclerosis: A Prospective Observational Study

Scientific Title

The Relationship between Periodontitis and Atherosclerosis in Patients with Acute Coronary Syndrome and The Impact for Periodontal Treatment to Atherosclerosis: A Prospective Observational Study

Scientific Title:Acronym

The Relationship between Periodontitis and Atherosclerosis in Patients with Acute Coronary Syndrome and The Impact for Periodontal Treatment to Atherosclerosis: A Prospective Observational Study

Region

Japan


Condition

Condition

Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate whether there is a relationship between the severity of periodontitis and the severity of arteriosclerotic lesions in patients who developed acute coronary syndrome, and evaluate the effect of periodontal treatment to arteriosclerotic lesions in the chronic phase.

Basic objectives2

Others

Basic objectives -Others

Investigation of the relationship between periodontitis and arteriosclerosis in patients with acute coronary syndrome

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The severity of periodontitis and the complexity of coronary lesions(SYNTAX Score, ACC/AHA morphological classification), Correlation of degree of yellow plaque on coronary angioscopy, and The severity of periodontitis and the complexity of coronary lesions (SYNTAX Score, ACC/AHA morphological classification) in the chronic phase (after periodontal treatment or dental education if necessary), Rate of change in degree of yellow plaque on coronary angioscopy

Key secondary outcomes

1. Relationship between periodontitis and degree of plaque on aortic angioscopy
2. Relationship between periodontitis and evaluation of arteriosclerotic changes by other tests (optical coherence tomography: OCT, coronary flow reserve: CFR, carotid echo, cardiac magnetic resonance imaging: MRI, etc.)


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

1. Those undergoing coronary angiography or revascularization at acute coronary syndrome
2. Those who are 20 years of age or older when obtaining consent
3. Those who have received sufficient explanation for participation in this study, and who have fully understood and have given the written consent of the research subject. (However, in cases where it is difficult to obtain consent from the person due to dementia, etc., consent by relatives within two relatives is permitted.)
4. Those with a high risk of periodontal disease (those with oral symptoms, those with a clearly small number of teeth, those with arteriosclerosis risk such as smoking and diabetes)

Key exclusion criteria

1. Those who applied for refusal to participate in this study
2. Those who are difficult to conduct coronary angiography due to general condition, advanced dementia, etc.
3. Those who are deemed inappropriate by the principal investigator

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Okumura

Organization

Division of Cardiology, Department of Medicine, Nihon University School of Medicine

Division name

Cardiology

Zip code

1738610

Address

Oyaguchijomachi 30-1, Itabashi-ku, Tokyo, Japan

TEL

+81-3-3972-8111

Email

okumura.yasuo@nihon-u.ac.jp


Public contact

Name of contact person

1st name Rikku
Middle name
Last name Arai

Organization

Division of Cardiology, Department of Medicine, Nihon University School of Medicine

Division name

Cardiology

Zip code

1738610

Address

Oyaguchijomachi 30-1, Itabashi-ku, Tokyo, Japan

TEL

+81-3-3972-8111

Homepage URL


Email

arai.riku@nihon-u.ac.jp


Sponsor or person

Institute

Division of Cardiology, Department of Medicine, Nihon University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Cardiology, Department of Medicine, Nihon University School of Medicine

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

Clinical research center, Nihon University Itabashi Hospital

Address

30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan

Tel

03-3972-8111

Email

komoda.nozomi@nihon-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

2019 Year 11 Month 18 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

33

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

2019 Year 05 Month 07 Day

Date of IRB

2019 Year 07 Month 10 Day

Anticipated trial start date

2019 Year 08 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none

May 22, 2023, ongoing.


Management information

Registered date

2019 Year 11 Month 18 Day

Last modified on

2023 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044000


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name