Myocardial InfarctionNCT05314192
Non-invasive Assessment of Inflammatory Markers MIP-1 Alpha and IL-6 in Saliva of Post Myocardial Infarction and Stage 4 Periodontitis Patients
An observational study of Myocardial Infarction and Periodontal Diseases, run by Ajman University at 1 site in India.
Trial summary
Periodontitis is an immunoinflammatory disease caused by microorganisms leading to sequential loss of the supporting structures of periodontium, resulting in periodontal pocket formation, gingival recession eventually leading to tooth loss.[1] A bacterial plaque is formed during the destructive changes of the… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Periodontal Diseases
- What is being tested?
- salivary test
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2021to 20 Apr 2021
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients included in the study were categorized into four groups: (1) group 1-healthy subjects, (2) group 2-stage 4 periodontitis patients, (3) group 3- post-MI patients with stage 4 periodontitis, (4) group 4- post-MI patients without periodontitis.
Who may be able to join
- subjects who had MI
- who had stage 4 periodontal disease
Who cannot join
- subjects who did not have MI
- subjects who had systemic disease other than MI
- subjects who had medication in the past 3 months
- smokers
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis is an immunoinflammatory disease caused by microorganisms leading to sequential loss of the supporting structures of periodontium, resulting in periodontal pocket formation, gingival recession eventually leading to tooth loss.[1] A bacterial plaque is formed during the destructive changes of the periodontium which initiates a host of inflammatory and immune responses.[2] These inflammatory responses may also cause an increase in inflammatory activities in atherosclerotic lesions in the coronary arteries resulting in the increased risk of cardiovascular events like myocardial infarction.[3] Myocardial infarction (MI) is a cardiovascular condition that occurs when there is deprivation of oxygen in the heart muscle is due to the sudden interruption of the blood supply resulting from the coronary artery blockage by a plaque causing myocardial ischemia and cell death. Inflammation is pivotal in the initiation and progression of atherosclerosis. Various cytokines and chemokines are released during inflammation.[4] These inflammatory markers may have diagnostic potential for the detection of various inflammatory diseases.[5] Macrophages secrete macrophage inflammatory protein-1 alpha (MIP-1 alpha) which recruits inflammatory cells, inhibits stem cells, and activates bone resorption cells.[6] Interleukin-6 (IL-6) is produced in response to tissue injury and infection and contributes to the differentiation of B cells, the proliferation of T cells, and bone resorption.[7] The levels of these inflammatory markers are seen to be increased in inflammatory conditions, which include myocardial infarction and stage 4 periodontitis. Therefore, this study aims to assess the levels of these inflammatory markers in patients with myocardial infarction and periodontitis.
Read the detailed description
This was a cross-sectional study involving the patients of the department of periodontics and department of cardiology.
Patients included in the study were categorized into four groups: (1) group 1-healthy subjects, (2) group 2-stage 4 periodontitis patients, (3) group 3- post-MI patients with stage 4 periodontitis, (4) group 4- post-MI patients without periodontitis.
The severity of the periodontitis was assessed by a periodontist. The diagnosis of acute MI was made by the cardiologists. Oral health assessment in acute MI patients was done at the subjects' bedside after stabilization of the patient, so as not to interfere with the ongoing medical treatment. Subjects' identification was kept confidential.
All samples were collected from patients admitted within 48 hours of their cardiac event. Patients were diagnosed as acute ST-elevation myocardial infarction (STEMI) based on the elevation of ST segments on the electrocardiogram(ECG) by 0.1mV in contiguous leads in patients with signs and symptoms of myocardial ischemia and/ or development of new left bundle branch block, along with increased cardiac biomarkers. Non-ST-elevation myocardial infarction (NSTEMI) was diagnosed in patients with signs and symptoms of myocardial ischemia and depression in ST-segment on the ECG or new Q wave pathology along with elevation of cardiac biomarkers.[8] Stage four periodontitis was diagnosed using the World Workshop 2017 classification.[9] Subjects who had undergone oral prophylaxis or periodontal surgery in the past 6 months were not included in the study. Smokers, pregnant women, lactating mothers, and those on medication (anti-microbial, non-steroidal anti-inflammatory drugs) in the past 3 months as well as those with other chronic systemic diseases were excluded from the study. These were all excluded as each would affect the levels of biomarkers.
- Conditions
- Myocardial Infarction, Periodontal Diseases
- Being tested
- salivary test
- Keywords
- MIP-1 Alpha, IL-6, Myocardial infarction, Periodontal disease
- Medical subject headings
- Myocardial Infarction, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salivary testDiagnostic test
saliva was assessed for MIP-1 alpha
salivary testDiagnostic test
saliva was assessed for IL-6
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy cohorts with no underlying systemic or periodontal disease Receives: Diagnostic Test: salivary test | |
| stage 2 periodontitis | patients with periodontitis but no underlying systemic periodontal disease Receives: Diagnostic Test: salivary test | |
| MI patients with stage 4 periodontitis | patients who had MI and having stage 4 periodontitis patients Receives: Diagnostic Test: salivary test | |
| MI patients without periodontitis | patients who had MI without periodontitis Receives: Diagnostic Test: salivary test |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary test for MIP-1 alpha
saliva was assessed for biomarker MIP-1 alpha among the 4 groups
Measured: 72 hours
salivary test for IL-6
saliva was assessed for biomarker IL-6 among the 4 groups
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Mar 2021
- Primary completion15 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajman University
- Sponsor type
- University, hospital or other
- Collaborators
- A B Shetty Memorial Institute of Dental Science
- Responsible party
- Principal investigator, sudhir rama varma, Ajman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314192
- Sponsor's protocol ID
- ABSM/EC/29/2020
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The link will be shared among researchers upon request
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessment of Inflammatory Markers MIP-1 Alpha and IL-6 in Saliva of Post Myocardial Infarction and Stage 4 Periodontitis Patients
- ClinicalTrials.gov ID
- NCT05314192
- Acronym / sponsor ID
- ABSM/EC/29/2020
- Conditions
- Myocardial Infarction, Periodontal Diseases
- Keywords
- MIP-1 Alpha, IL-6, Myocardial infarction, Periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ajman UniversityUniversity, hospital or other
- Collaborators
- A B Shetty Memorial Institute of Dental Science
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 6 Apr 2022 (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.
Periodontitis is an immunoinflammatory disease caused by microorganisms leading to sequential loss of the supporting structures of periodontium, resulting in periodontal pocket formation, gingival recession eventually leading to tooth loss.[1] A bacterial plaque is formed during the destructive changes of the periodontium which initiates a host of inflammatory and immune responses.[2] These inflammatory responses may also cause an increase in inflammatory activities in atherosclerotic lesions in the coronary arteries resulting in the increased risk of cardiovascular events like myocardial infarction.[3] Myocardial infarction (MI) is a cardiovascular condition that occurs when there is deprivation of oxygen in the heart muscle is due to the sudden interruption of the blood supply resulting from the coronary artery blockage by a plaque causing myocardial ischemia and cell death. Inflammation is pivotal in the initiation and progression of atherosclerosis. Various cytokines and chemokines are released during inflammation.[4] These inflammatory markers may have diagnostic potential for the detection of various inflammatory diseases.[5] Macrophages secrete macrophage inflammatory protein-1 alpha (MIP-1 alpha) which recruits inflammatory cells, inhibits stem cells, and activates bone resorption cells.[6] Interleukin-6 (IL-6) is produced in response to tissue injury and infection and contributes to the differentiation of B cells, the proliferation of T cells, and bone resorption.[7] The levels of these inflammatory markers are seen to be increased in inflammatory conditions, which include myocardial infarction and stage 4 periodontitis. Therefore, this study aims to assess the levels of these inflammatory markers in patients with myocardial infarction and periodontitis.
Detailed description
This was a cross-sectional study involving the patients of the department of periodontics and department of cardiology.
Patients included in the study were categorized into four groups: (1) group 1-healthy subjects, (2) group 2-stage 4 periodontitis patients, (3) group 3- post-MI patients with stage 4 periodontitis, (4) group 4- post-MI patients without periodontitis.
The severity of the periodontitis was assessed by a periodontist. The diagnosis of acute MI was made by the cardiologists. Oral health assessment in acute MI patients was done at the subjects' bedside after stabilization of the patient, so as not to interfere with the ongoing medical treatment. Subjects' identification was kept confidential.
All samples were collected from patients admitted within 48 hours of their cardiac event. Patients were diagnosed as acute ST-elevation myocardial infarction (STEMI) based on the elevation of ST segments on the electrocardiogram(ECG) by 0.1mV in contiguous leads in patients with signs and symptoms of myocardial ischemia and/ or development of new left bundle branch block, along with increased cardiac biomarkers. Non-ST-elevation myocardial infarction (NSTEMI) was diagnosed in patients with signs and symptoms of myocardial ischemia and depression in ST-segment on the ECG or new Q wave pathology along with elevation of cardiac biomarkers.[8] Stage four periodontitis was diagnosed using the World Workshop 2017 classification.[9] Subjects who had undergone oral prophylaxis or periodontal surgery in the past 6 months were not included in the study. Smokers, pregnant women, lactating mothers, and those on medication (anti-microbial, non-steroidal anti-inflammatory drugs) in the past 3 months as well as those with other chronic systemic diseases were excluded from the study. These were all excluded as each would affect the levels of biomarkers.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: salivary testHealthy cohorts with no underlying systemic or periodontal disease |
| stage 2 periodontitis | – | Diagnostic Test: salivary testpatients with periodontitis but no underlying systemic periodontal disease |
| MI patients with stage 4 periodontitis | – | Diagnostic Test: salivary testpatients who had MI and having stage 4 periodontitis patients |
| MI patients without periodontitis | – | Diagnostic Test: salivary testpatients who had MI without periodontitis |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included in the study were categorized into four groups: (1) group 1-healthy subjects, (2) group 2-stage 4 periodontitis patients, (3) group 3- post-MI patients with stage 4 periodontitis, (4) group 4- post-MI patients without periodontitis.
Key inclusion criteria (2 listed)
- subjects who had MI
- who had stage 4 periodontal disease
Key exclusion criteria (5 listed)
- subjects who did not have MI
- subjects who had systemic disease other than MI
- subjects who had medication in the past 3 months
- smokers
- pregnant and lactating women
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 |
|---|---|---|
| salivary testsaliva was assessed for MIP-1 alpha | Diagnostic test | Healthy, MI patients with stage 4 periodontitis, MI patients without periodontitis, stage 2 periodontitis |
| salivary testsaliva was assessed for IL-6 | Diagnostic test | Healthy, MI patients with stage 4 periodontitis, MI patients without periodontitis, stage 2 periodontitis |
Primary outcome
salivary test for MIP-1 alpha
Time frame: 72 hours
saliva was assessed for biomarker MIP-1 alpha among the 4 groups
salivary test for IL-6
Time frame: 72 hours
saliva was assessed for biomarker IL-6 among the 4 groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Undecided. The link will be shared among researchers upon request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Periodontal Diseases, run by Ajman University at 1 site in India.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 6 Apr 2022. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary test for MIP-1 alpha (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2022.