Acute Myocardial InfarctionNCT04012541
Comprehensive Oral Intervention in Patients With AMI
A study testing active dental procedure, post-myocardial infarction management and basic periodontal examinations in people with Acute Myocardial Infarction and Dental Diseases, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Dental Diseases
- What is being tested?
- active dental procedure, post-myocardial infarction management and basic periodontal examinations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Patients suspected of having active infection
- Those who are taking long-term systemic antibiotics or receiving immunosuppressive treatment
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Si-Hyuck Kang, MD, 82317877027, eandp303@gmail.com
Ji Yeon Yoon, 82317873974, r1999@snubh.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Myocardial Infarction, Dental Diseases
- Being tested
- active dental procedure, post-myocardial infarction management, basic periodontal examinations
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active dental procedureProcedure or surgery
scaling and root planing
post-myocardial infarction managementDrug
Also called dual antiplatelet drug
aspirin, clopidogrel, ticagrelor
basic periodontal examinationsRadiation
panorama radiograph : full mouth periapical radiograph
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | 1. post-myocardial infarction management
2. basic periodontal examinations
3. active dental procedure Receives: Procedure: active dental procedure; Drug: post-myocardial infarction management; Radiation: basic periodontal examinations |
| control group | Active comparator | 1. post-myocardial infarction management
2. basic periodontal examinations Receives: Drug: post-myocardial infarction management; Radiation: basic periodontal examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
hsCRP
hsCRP(high sensitivity C-reactive protein), mg/dL
Measured: at 3 months
Secondary outcomes (10)
surrogate blood markers
FBS \& Total cholesterol \& LDL-cholesterol \& HDL-cholesterol \& Triglyceride \& Apolipoprotein A \& Apolipoprotein B, mg/dL
Measured: at 3 months
patient symptom
NYHA functional class
Measured: at 3 months & 12 months
Systolic & diastolic blood pressure
automated blood pressure, mmHg
Measured: at 3 months & 12 months
Exercise performance
Treadmill test
Measured: at 3 months
Death
number of cardiovascular death
Measured: at 12 months
unscheduled coronary revascularization
number of unscheduled coronary revascularization
Measured: at 12 months
stroke
number of stroke
Measured: at 12 months
HF admission
number of HF admission
Measured: at 12 months
unstable angina
number of unstable angina
Measured: at 12 months
recurrent MI
number of recent MI
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start5 Jul 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Si-Hyuck Kang, Seoul National University Bundang Hospital
- Investigators
- Si-Hyuck Kang, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012541
- Sponsor's protocol ID
- AMI oral intervention
- Status last verified
- Jul 2019
- First submitted
- 14 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36194420
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Comprehensive Oral Intervention in Patients With Acute Myocardial Infarction: a Pilot Study
- ClinicalTrials.gov ID
- NCT04012541
- Acronym / sponsor ID
- AMI oral intervention
- Conditions
- Acute Myocardial Infarction, Dental Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Procedure: active dental procedure, Drug: post-myocardial infarction management, Radiation: basic periodontal examinations1. post-myocardial infarction management 2. basic periodontal examinations 3. active dental procedure |
| control group | Active comparator | Drug: post-myocardial infarction management, Radiation: basic periodontal examinations1. post-myocardial infarction management 2. basic periodontal examinations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- clinical exclusion criteria
- periodontal exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active dental procedurescaling and root planing | Procedure or surgery | treatment group |
| post-myocardial infarction managementAlso: dual antiplatelet drugaspirin, clopidogrel, ticagrelor | Drug | control group, treatment group |
| basic periodontal examinationspanorama radiograph : full mouth periapical radiograph | Radiation | control group, treatment group |
Primary outcome
hsCRP
Time frame: at 3 months
hsCRP(high sensitivity C-reactive protein), mg/dL
10 secondary outcomes
surrogate blood markers
Time frame: at 3 months
patient symptom
Time frame: at 3 months & 12 months
Systolic & diastolic blood pressure
Time frame: at 3 months & 12 months
Exercise performance
Time frame: at 3 months
Death
Time frame: at 12 months
unscheduled coronary revascularization
Time frame: at 12 months
stroke
Time frame: at 12 months
HF admission
Time frame: at 12 months
unstable angina
Time frame: at 12 months
recurrent MI
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Derived from this study: PubMed 36194420Ye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Si-Hyuck Kang, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active dental procedure, post-myocardial infarction management and basic periodontal examinations in people with Acute Myocardial Infarction and Dental Diseases, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Si-Hyuck Kang, MD (82317877027, eandp303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hsCRP (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.