Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04012541
Other study ID # AMI oral intervention
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04451967 - Acute Myocardial Infarction Study in Northeastern China
Completed NCT05974397 - Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
Not yet recruiting NCT04072081 - Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03707626 - Collateral Circulation to LAD and Wellens Sign
Completed NCT02669810 - EXCELLENT (EXpanded CELL ENdocardiac Transplantation) Phase 2
Not yet recruiting NCT04104048 - Short Term Outcome of Primary Precutaneous Coronary Intervention in Ostial Versus Non Ostial Culprit Proximal Left Anterior Descending Artery Acute Myocardial Infraction
Active, not recruiting NCT02915107 - The SORT OUT IX STEMI OCT Trial N/A
Completed NCT02896543 - The Relationship of Change of Dendritic Cells Fractalkine and P-selectin Patients With Acute Myocardial Infarction N/A
Completed NCT02490969 - Copeptin Registry (proCORE) Biomarkers in Cardiology (BIC)-19 N/A
Withdrawn NCT01901471 - Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock Phase 2
Completed NCT02531165 - Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention N/A
Completed NCT02312336 - A Pilot Study of Transcoronary Myocardial Cooling N/A
Recruiting NCT02071342 - Study of ABSORB Stent in Acute Myocardial Infarction N/A
Completed NCT02070913 - COOL-AMI EU Case Series Clinical Study
Terminated NCT01972126 - MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction N/A
Completed NCT01887080 - Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program N/A
Withdrawn NCT01678339 - Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients N/A
Completed NCT01216995 - Safety and Efficacy of Adipose Derived Regenerative Cells (ADRCs) Delivered Via the Intracoronary Route in the Treatment of Patients With ST-elevation Acute Myocardial Infarction (AMI) Phase 2
Completed NCT01627457 - Heart Cycle Prestudy N/A