NCT04012541

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 9, 2019

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

June 14, 2019

Last Update Submit

July 8, 2019

Conditions

Acute Myocardial InfarctionDental Diseases

Outcome Measures

Primary Outcomes (1)

  • hsCRP

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

    at 3 months

Secondary Outcomes (10)

  • surrogate blood markers

    at 3 months

  • patient symptom

    at 3 months & 12 months

  • Systolic & diastolic blood pressure

    at 3 months & 12 months

  • Exercise performance

    at 3 months

  • Death

    at 12 months

  • +5 more secondary outcomes

Study Arms (2)

treatment group

EXPERIMENTAL

1. post-myocardial infarction management 2. basic periodontal examinations 3. active dental procedure

Procedure: active dental procedureDrug: post-myocardial infarction managementRadiation: basic periodontal examinations

control group

ACTIVE COMPARATOR

1. post-myocardial infarction management 2. basic periodontal examinations

Drug: post-myocardial infarction managementRadiation: basic periodontal examinations

Interventions

active dental procedurePROCEDURE

scaling and root planing

treatment group
post-myocardial infarction managementDRUG

aspirin, clopidogrel, ticagrelor

Also known as: dual antiplatelet drug
control grouptreatment group
basic periodontal examinationsRADIATION

panorama radiograph : full mouth periapical radiograph

control grouptreatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36194420DERIVED

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

  • Si-Hyuck Kang, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Si-Hyuck Kang, MD

CONTACT

82317877027eandp303@gmail.com

Ji Yeon Yoon

CONTACT

82317873974r1999@snubh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2019

First Posted

July 9, 2019

Study Start

July 5, 2019

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 9, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)