Comprehensive Oral Intervention in Patients With AMI

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012541
• Other study ID #: AMI oral intervention
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2019
• Source: Seoul National University Bundang Hospital
• Contact: Si-Hyuck Kang, MD
• Phone: 82317877027
• Email: eandp303[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Dental Diseases
• Infarction
• Myocardial Infarction
• Stomatognathic Diseases

Intervention

Procedure:
• active dental procedure
scaling and root planing

Drug:
• post-myocardial infarction management
aspirin, clopidogrel, ticagrelor

Radiation:
• basic periodontal examinations
panorama radiograph : full mouth periapical radiograph

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hsCRP	hsCRP(high sensitivity C-reactive protein), mg/dL	at 3 months
Secondary	surrogate blood markers	FBS & Total cholesterol & LDL-cholesterol & HDL-cholesterol & Triglyceride & Apolipoprotein A & Apolipoprotein B, mg/dL	at 3 months
Secondary	patient symptom	NYHA functional class	at 3 months & 12 months
Secondary	Systolic & diastolic blood pressure	automated blood pressure, mmHg	at 3 months & 12 months
Secondary	Exercise performance	Treadmill test	at 3 months
Secondary	Death	number of cardiovascular death	at 12 months
Secondary	unscheduled coronary revascularization	number of unscheduled coronary revascularization	at 12 months
Secondary	stroke	number of stroke	at 12 months
Secondary	HF admission	number of HF admission	at 12 months
Secondary	unstable angina	number of unstable angina	at 12 months
Secondary	recurrent MI	number of recent MI	at 12 months