Comprehensive Oral Intervention in Patients With AMI

Not Applicable

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

• Registration Number: NCT04012541
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study First Submitted: 2019-06-14
• Status Verified: 2019-07
• Study Start: 2019-07-05
• Study First Submitted QC: 2019-07-08
• Last Update Submitted: 2019-07-08
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	active dental procedure	1. post-myocardial infarction management 2. basic periodontal examinations 3. active dental procedure
treatment group	basic periodontal examinations	1. post-myocardial infarction management 2. basic periodontal examinations 3. active dental procedure
control group	post-myocardial infarction management	1. post-myocardial infarction management 2. basic periodontal examinations
control group	basic periodontal examinations	1. post-myocardial infarction management 2. basic periodontal examinations
treatment group	post-myocardial infarction management	1. post-myocardial infarction management 2. basic periodontal examinations 3. active dental procedure

Primary Outcome Measures

Name	Time	Method
hsCRP	at 3 months	hsCRP(high sensitivity C-reactive protein), mg/dL

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of