Comprehensive Oral Intervention in Patients With AMI

July 8, 2019 updated by: Si-Hyuck Kang, Seoul National University Bundang Hospital

A Randomized Control Trial of Comprehensive Oral Intervention in Patients With Acute Myocardial Infarction: a Pilot Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
  1. post-myocardial infarction management
  2. basic periodontal examinations
  3. active dental procedure
Procedure: active dental procedure
scaling and root planing
Drug: post-myocardial infarction management
aspirin, clopidogrel, ticagrelor
Other Names:
  • dual antiplatelet drug
Radiation: basic periodontal examinations
panorama radiograph : full mouth periapical radiograph
Active Comparator: control group
  1. post-myocardial infarction management
  2. basic periodontal examinations
Drug: post-myocardial infarction management
aspirin, clopidogrel, ticagrelor
Other Names:
  • dual antiplatelet drug
Radiation: basic periodontal examinations
panorama radiograph : full mouth periapical radiograph

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hsCRP
Time Frame: at 3 months
hsCRP(high sensitivity C-reactive protein), mg/dL
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surrogate blood markers
Time Frame: at 3 months
FBS & Total cholesterol & LDL-cholesterol & HDL-cholesterol & Triglyceride & Apolipoprotein A & Apolipoprotein B, mg/dL
at 3 months
patient symptom
Time Frame: at 3 months & 12 months
NYHA functional class
at 3 months & 12 months
Systolic & diastolic blood pressure
Time Frame: at 3 months & 12 months
automated blood pressure, mmHg
at 3 months & 12 months
Exercise performance
Time Frame: at 3 months
Treadmill test
at 3 months
Death
Time Frame: at 12 months
number of cardiovascular death
at 12 months
unscheduled coronary revascularization
Time Frame: at 12 months
number of unscheduled coronary revascularization
at 12 months
stroke
Time Frame: at 12 months
number of stroke
at 12 months
HF admission
Time Frame: at 12 months
number of HF admission
at 12 months
unstable angina
Time Frame: at 12 months
number of unstable angina
at 12 months
recurrent MI
Time Frame: at 12 months
number of recent MI
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

National Research Foundation of Korea

Investigators

  • Principal Investigator: Si-Hyuck Kang, MD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2019

Primary Completion (Anticipated)

March 31, 2021

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMI oral intervention

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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