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Comprehensive Oral Intervention in Patients With AMI

Primary Purpose

Acute Myocardial Infarction, Dental Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
active dental procedure
post-myocardial infarction management
basic periodontal examinations
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults over 18
  • Patients diagnosed with type 1 or 2 MI according to the Fourth Universal Definition of Myocardial Infarction (2018) criteria
  • Patients with baseline hsCRP (high-sensitivity C-reactive protein) elevated above 1.0 mg / dL

Exclusion Criteria:

  1. clinical exclusion criteria

    • Inability to provide informed consent
    • Patients who are predicted to have low compliance
    • Those whose life expectancy is less than 3 months due to cardiovascular disease or other reasons
    • Those who are considered to be too poor condition to perform dental treatment or have a high risk of bleeding
    • Those who need active dental treatment such as extraction
    • Patients suspected of having active infection
    • Those who are taking long-term systemic antibiotics or receiving immunosuppressive treatment

  2. periodontal exclusion criteria

    • Fully edentulous (Except for fixed implant restorations)
    • If more than 15 teeth and implants do not exist
    • If the last dental visit experience is less than 6 months
    • If periodontal treatment is not possible by the researcher

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treatment group

control group

Arm Description

post-myocardial infarction management basic periodontal examinations active dental procedure

post-myocardial infarction management basic periodontal examinations

Outcomes

Primary Outcome Measures

hsCRP
hsCRP(high sensitivity C-reactive protein), mg/dL

Secondary Outcome Measures

surrogate blood markers
FBS & Total cholesterol & LDL-cholesterol & HDL-cholesterol & Triglyceride & Apolipoprotein A & Apolipoprotein B, mg/dL
patient symptom
NYHA functional class
Systolic & diastolic blood pressure
automated blood pressure, mmHg
Exercise performance
Treadmill test
Death
number of cardiovascular death
unscheduled coronary revascularization
number of unscheduled coronary revascularization
stroke
number of stroke
HF admission
number of HF admission
unstable angina
number of unstable angina
recurrent MI
number of recent MI

Full Information

First Posted
June 14, 2019
Last Updated
July 8, 2019
Sponsor
Seoul National University Bundang Hospital
Collaborators
National Research Foundation of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04012541
Brief Title
Comprehensive Oral Intervention in Patients With AMI
Official Title
A Randomized Control Trial of Comprehensive Oral Intervention in Patients With Acute Myocardial Infarction: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
National Research Foundation of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The investigators performed a randomized controlled trial with investigator-masked design enrolling subjects with acute myocardial infarction. The purpose of this study is to find a treatment strategy to reduce the risk of recurrence of myocardial infarction through oral hygiene improvement.
Detailed Description
Subjects were divided into a treatment group and a control group. Both sides receive basic periodontal examinations, but the treatment group receives active dental procedure such as scaling and root planing. Both groups also receive post-myocardial infarction management. As part of a pilot study, this study used the primary outcome measure for changes in surrogate markers rather than clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Dental Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is randomized controlled trial. Patients who agreed to the study were randomly assigned to the intervention group and control group at a 1: 1 ratio.
Masking
Investigator
Masking Description
Participating patients and dentists are not able to blind information about random allocation. However, in order to reduce the bias, the cardiologist who treats the patient and prescribes the medicines performs an investigator-masked design that masks information about the treatment group.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
post-myocardial infarction management basic periodontal examinations active dental procedure
Arm Title
control group
Arm Type
Active Comparator
Arm Description
post-myocardial infarction management basic periodontal examinations
Intervention Type
Procedure
Intervention Name(s)
active dental procedure
Intervention Description
scaling and root planing
Intervention Type
Drug
Intervention Name(s)
post-myocardial infarction management
Other Intervention Name(s)
dual antiplatelet drug
Intervention Description
aspirin, clopidogrel, ticagrelor
Intervention Type
Radiation
Intervention Name(s)
basic periodontal examinations
Intervention Description
panorama radiograph : full mouth periapical radiograph
Primary Outcome Measure Information:
Title
hsCRP
Description
hsCRP(high sensitivity C-reactive protein), mg/dL
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
surrogate blood markers
Description
FBS & Total cholesterol & LDL-cholesterol & HDL-cholesterol & Triglyceride & Apolipoprotein A & Apolipoprotein B, mg/dL
Time Frame
at 3 months
Title
patient symptom
Description
NYHA functional class
Time Frame
at 3 months & 12 months
Title
Systolic & diastolic blood pressure
Description
automated blood pressure, mmHg
Time Frame
at 3 months & 12 months
Title
Exercise performance
Description
Treadmill test
Time Frame
at 3 months
Title
Death
Description
number of cardiovascular death
Time Frame
at 12 months
Title
unscheduled coronary revascularization
Description
number of unscheduled coronary revascularization
Time Frame
at 12 months
Title
stroke
Description
number of stroke
Time Frame
at 12 months
Title
HF admission
Description
number of HF admission
Time Frame
at 12 months
Title
unstable angina
Description
number of unstable angina
Time Frame
at 12 months
Title
recurrent MI
Description
number of recent MI
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults over 18 Patients diagnosed with type 1 or 2 MI according to the Fourth Universal Definition of Myocardial Infarction (2018) criteria Patients with baseline hsCRP (high-sensitivity C-reactive protein) elevated above 1.0 mg / dL Exclusion Criteria: clinical exclusion criteria Inability to provide informed consent Patients who are predicted to have low compliance Those whose life expectancy is less than 3 months due to cardiovascular disease or other reasons Those who are considered to be too poor condition to perform dental treatment or have a high risk of bleeding Those who need active dental treatment such as extraction Patients suspected of having active infection Those who are taking long-term systemic antibiotics or receiving immunosuppressive treatment periodontal exclusion criteria Fully edentulous (Except for fixed implant restorations) If more than 15 teeth and implants do not exist If the last dental visit experience is less than 6 months If periodontal treatment is not possible by the researcher
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Si-Hyuck Kang, MD
Phone
82317877027
Email
eandp303@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Yeon Yoon
Phone
82317873974
Email
r1999@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Si-Hyuck Kang, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si-Hyuck Kang, MD
Phone
82317877027
Email
eandp303@gmail.com
First Name & Middle Initial & Last Name & Degree
Ji Yeon Yoon
Phone
82317873974
Email
r1999@snubh.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36194420
Citation
Ye Z, Cao Y, Miao C, Liu W, Dong L, Lv Z, Iheozor-Ejiofor Z, Li C. Periodontal therapy for primary or secondary prevention of cardiovascular disease in people with periodontitis. Cochrane Database Syst Rev. 2022 Oct 4;10(10):CD009197. doi: 10.1002/14651858.CD009197.pub5.
Results Reference
derived

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Comprehensive Oral Intervention in Patients With AMI

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