Comprehensive Oral Intervention in Patients With AMI

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: Acute Myocardial Infarction; Dental Diseases
• Intervention / Treatment: Procedure: active dental procedure; Drug: post-myocardial infarction management; Radiation: basic periodontal examinations

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

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Si-Hyuck Kang, MD; Phone Number: 82317877027; Email: eandp303@gmail.com
      • Contact: Ji Yeon Yoon; Phone Number: 82317873974; Email: r1999@snubh.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; post-myocardial infarction management; basic periodontal examinations; 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; post-myocardial infarction management; 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	hsCRP(high sensitivity C-reactive protein), mg/dL	at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

General Publications

• 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.

Study record dates

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: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Stomatognathic Diseases; Platelet Aggregation Inhibitors
• 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