Coronary StenosisATHERODENTNCT03395041
Periodontal Disease, Inflammation and Acute Coronary Syndromes
An observational study of Coronary Stenosis and Periodontal Diseases, run by Cardio Med Medical Center at 1 site in Romania.
Trial summary
Recent studies have shown that the systemic inflammation caused by periodontal disease (PD) can determine important changes in the coronary arteries, favoring atherosclerosis progression and development of acute coronary syndromes (ACS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Periodontal Diseases, Acute Coronary Syndrome
- What is being tested?
- cardiac imaging tests
- How many people
- 149 participants
- Where
- 1 siteRomania
- Study dates
- 15 May 2018to 1 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndromes (unstable angina or NSTEMI), who undergo invasive coronary angiography +/- revascularization (according to local protocols).
Who may be able to join
- Patients aged at least 18 years;
- Patients who have signed the written informed consent;
- Patients with ACS (unstable angina or non-ST segment elevation myocardial infarction) occurring with maximum 7 days prior to enrollment
Who cannot join
- Patient's refusal to participate in the study;
- Sensitivity to the contrast substance;
- Women of reproductive age who do not use contraceptive methods;
- Pregnant women;
- Any malignancy within the last 5 years;
- Any disease or comorbidity that can reduce life expectancy to less than 2 years;
- Acute or chronic renal failure;
- Non-compliant patients who, in the opinion of the investigators, will not present to follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Disease, Inflammation and Atherosclerosis Progression in Patients With Acute Coronary Syndromes - the ATHERODENT Study
Recent studies have shown that the systemic inflammation caused by periodontal disease (PD) can determine important changes in the coronary arteries, favoring atherosclerosis progression and development of acute coronary syndromes (ACS). The aim of ATHERODENT study is to assess the interrelation between PD, inflammation and progression of coronary atherosclerosis in patients with ACS. Material and methods: This case-control observational study will enroll 100 patients (group 1 - ACS and associated PD, and group 2 -ACS and no PD), in whom the following data will be collected: (1) demographic and clinical data, (2) cardiovascular risk factors, (3) full characterization of PD markers, (4) systemic inflammatory biomarkers, (5) imaging biomarkers derived from transthoracic echocardiography, computed tomography, coronary angiography, optical coherence tomography and intravascular ultrasound, and (6) assessment of the presence of specific oral bacteria in samples of coronary plaques collected by coronary atherectomy, which will be performed during percutaneous revascularization interventions, when indicated in selected cases, in the atherectomy sub-study. The follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months. The primary endpoint of the study will be represented by the rate of major adverse cardiovascular events (MACE rates) in PD vs non-PD patients and in correlation with: (1) the level of systemic inflammation triggered by PD and/or by ACS at baseline; (2) the vulnerability degree of atheromatous plaques in the coronary tree (culprit and non-culprit lesions); and (3) the presence and burden of oral bacteria in atheromatous plaques. Secondary endpoints will be represented by: (1) the rate of progression of vulnerability degree of non-culprit coronary plaques; (2) the rate of progression of atheromatous burden and calcium scoring of the coronary tree; and (3) the rate of occurrence of left ventricular remodeling and postinfarction heart failure.
Read the detailed description
ATHERODENT is a case-controlled observational clinical study, conducted in two clinical sites: University of Medicine and Pharmacy Tirgu Mures, Romania, and Cardio Med Medical Center - Laboratory of Advanced Research in Multimodality Imaging.
The primary objective of ATHERODENT is to assess the interrelation between PD, inflammation and atherosclerosis progression in patients who suffered an ACS and have concomitant PD vs those with ACS and no PD, using (1) invasive and non-invasive imaging techniques for characterization of vulnerable coronary plaques; (2) full characterization of PD; and (3) complex assessment of systemic vulnerability based on systemic inflammation-related biomarkers.
The secondary objectives of ATHERODENT are:
- to study the correlation between PD and coronary plaque vulnerability
- to assess the correlation between PD and severity of coronary atherosclerosis
- to assess the presence and burden of oral bacteria in coronary atheromatous plaques collected during atherectomy and their relation with plaque vulnerability and evolution following an ACS (in the atherectomy sub-study).
Baseline will be considered as the moment of the index event and related hospitalization. The index event will be considered the ACS and patients will be randomized in the study at maximum 7 days post ACS. The follow-up visits will be performed at 1, 3, 6, 12, 15, 18 and 24 months after randomization.
The following procedures will be performed at baseline:
- recording of demographic and clinical data (age, gender, personal history)
- determination of serum lipids, blood counts, glycemia, urea, creatinine, liver enzymes
- determination of the biomarkers expressing the severity of the acute coronary syndrome and heart damage (hs-Troponin, NT-proBNP)
- determination of serum levels inflammatory biomarkers and adhesion molecules at the moment of the index event (hs-CRP, matrix metalloprotease, interleukin-6, VCAM, ICAM)
- determination of specific micro-RNAs related to plaque vulnerability
- echocardiography (+ speckle tracking) for assessment of left ventricular function and size
- full characterization of PD (dental plaque/tartar, gingival retraction, gingival bleeding, etc.)
- microbiological determination of oral bacteria from the periodontal pockets
- non-invasive imaging by coronary angioCT for all the coronary tree and characterization of vulnerability markers and atherosclerosis severity, using surrogate imaging biomarkers such as calcium score, necrotic core, plaque burden, low density atheroma, positive remodeling, epicardial fat volume
- invasive imaging performed during invasive revascularization procedures, using intracoronary imaging techniques (OCT, IVUS) and quantification of invasive imaging biomarkers in culprit and non-culprit lesions, such as macrophage content, thickness of fibrous cap and necrotic core.
- atherectomy of coronary culprit atheromatous plaques (in the atherectomy sub-study), performed during the revascularization procedure when indicated, in selected cases, followed by histological examination of the samples collected in order to identify specific antigens related to oral microbiota in the atheromatous tissue of coronary vulnerable plaques.
Follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months after randomization, including assessment of clinical data, echocardiography and registration of MACE and adverse events.
In addition, complex imaging assessment using Angio CT will be performed at 2 years to assess atherosclerosis progression.
- Conditions
- Coronary Stenosis, Periodontal Diseases, Acute Coronary Syndrome, Non-ST Elevation Myocardial Infarction, Unstable Angina, Acute Myocardial Infarction
- Being tested
- cardiac imaging tests
- Keywords
- vulnerable plaque, CT imaging, oral bacteria, inflammation
- Medical subject headings
- Coronary Stenosis, Periodontal Diseases, Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction, Angina, Unstable, Atherosclerosis, Plaque, Atherosclerotic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac imaging testsDiagnostic test
cardiac computed tomography, echocardiography, intravascular ultrasound, optical coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| ATD - SG 01 | Patients with acute coronary syndrome in whom dental examination performed in the first 7 days after the index event revealed the presence of periodontal disease.
They will undergo complex cardiac imaging tests to assess plaque vulnerability and severity of coronary artery disease. Receives: Diagnostic Test: cardiac imaging tests | |
| ATD - SG 02 | Patients with acute coronary syndrome in whom dental examination performed in the first 7 days after the index event did not reveal the presence of periodontal disease.
They will undergo complex cardiac imaging tests to assess plaque vulnerability and severity of coronary artery disease. Receives: Diagnostic Test: cardiac imaging tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of major adverse cardiovascular events (MACE rates).
Cardiac death, need for target vessel revascularization (with target vessel defined as the vessel with a vulnerable plaque), or reinfarction.
Measured: 24 months
Secondary outcomes (3)
The rate of progression of vulnerability degree of non-culprit coronary plaques
Increased severity in vulnerability indexes determined by cardiac imaging tests in the coronary tree
Measured: 24 months
The rate of progression of atheromatous burden and calcium scoring
Increase in atheromatous plaque burden and calcium scoring of the entire coronary tree as determined by Cardio CT
Measured: 24 months
The occurrence of left ventricular remodeling and post-infarction heart failure
Development of ventricular remodeling defined as increase in ventricular diameters with>15% compared to baseline, and of post-infarction heart failure, defined as left ventricular ejection fraction <45% in the posti-infarction period
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start15 May 2018
- Primary completion15 Jan 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardio Med Medical Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Targu Mures, Romania, University Hospital of Targu Mures, Romania
- Responsible party
- Sponsor
- Investigators
- Theodora Benedek, Prof, Principal investigator, University of Medicine and Pharmacy Tirgu Mures, CardioMed Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395041
- Sponsor's protocol ID
- CM0117-ATD
- Acronym
- ATHERODENT
- Status last verified
- Jul 2019
- First submitted
- 3 Jan 2018
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available to other researchers from the same group and to other collaborating groups and can be used for further statistical sub-analysis
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Disease, Inflammation and Atherosclerosis Progression in Patients With Acute Coronary Syndromes - the ATHERODENT Study
- ClinicalTrials.gov ID
- NCT03395041
- Acronym / sponsor ID
- ATHERODENT / CM0117-ATD
- Conditions
- Coronary Stenosis, Periodontal Diseases, Acute Coronary Syndrome, Non-ST Elevation Myocardial Infarction, Unstable Angina, Acute Myocardial Infarction
- Keywords
- vulnerable plaque, CT imaging, oral bacteria, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Cardio Med Medical CenterIndustry (pharma, biotech, devices)
- Collaborators
- University of Targu Mures, Romania, University Hospital of Targu Mures, Romania
- Study start
- 15 May 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 10 Jan 2018 (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.
Recent studies have shown that the systemic inflammation caused by periodontal disease (PD) can determine important changes in the coronary arteries, favoring atherosclerosis progression and development of acute coronary syndromes (ACS). The aim of ATHERODENT study is to assess the interrelation between PD, inflammation and progression of coronary atherosclerosis in patients with ACS. Material and methods: This case-control observational study will enroll 100 patients (group 1 - ACS and associated PD, and group 2 -ACS and no PD), in whom the following data will be collected: (1) demographic and clinical data, (2) cardiovascular risk factors, (3) full characterization of PD markers, (4) systemic inflammatory biomarkers, (5) imaging biomarkers derived from transthoracic echocardiography, computed tomography, coronary angiography, optical coherence tomography and intravascular ultrasound, and (6) assessment of the presence of specific oral bacteria in samples of coronary plaques collected by coronary atherectomy, which will be performed during percutaneous revascularization interventions, when indicated in selected cases, in the atherectomy sub-study. The follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months. The primary endpoint of the study will be represented by the rate of major adverse cardiovascular events (MACE rates) in PD vs non-PD patients and in correlation with: (1) the level of systemic inflammation triggered by PD and/or by ACS at baseline; (2) the vulnerability degree of atheromatous plaques in the coronary tree (culprit and non-culprit lesions); and (3) the presence and burden of oral bacteria in atheromatous plaques. Secondary endpoints will be represented by: (1) the rate of progression of vulnerability degree of non-culprit coronary plaques; (2) the rate of progression of atheromatous burden and calcium scoring of the coronary tree; and (3) the rate of occurrence of left ventricular remodeling and postinfarction heart failure.
Detailed description
ATHERODENT is a case-controlled observational clinical study, conducted in two clinical sites: University of Medicine and Pharmacy Tirgu Mures, Romania, and Cardio Med Medical Center - Laboratory of Advanced Research in Multimodality Imaging.
The primary objective of ATHERODENT is to assess the interrelation between PD, inflammation and atherosclerosis progression in patients who suffered an ACS and have concomitant PD vs those with ACS and no PD, using (1) invasive and non-invasive imaging techniques for characterization of vulnerable coronary plaques; (2) full characterization of PD; and (3) complex assessment of systemic vulnerability based on systemic inflammation-related biomarkers.
The secondary objectives of ATHERODENT are:
- to study the correlation between PD and coronary plaque vulnerability
- to assess the correlation between PD and severity of coronary atherosclerosis
- to assess the presence and burden of oral bacteria in coronary atheromatous plaques collected during atherectomy and their relation with plaque vulnerability and evolution following an ACS (in the atherectomy sub-study).
Baseline will be considered as the moment of the index event and related hospitalization. The index event will be considered the ACS and patients will be randomized in the study at maximum 7 days post ACS. The follow-up visits will be performed at 1, 3, 6, 12, 15, 18 and 24 months after randomization.
The following procedures will be performed at baseline:
- recording of demographic and clinical data (age, gender, personal history)
- determination of serum lipids, blood counts, glycemia, urea, creatinine, liver enzymes
- determination of the biomarkers expressing the severity of the acute coronary syndrome and heart damage (hs-Troponin, NT-proBNP)
- determination of serum levels inflammatory biomarkers and adhesion molecules at the moment of the index event (hs-CRP, matrix metalloprotease, interleukin-6, VCAM, ICAM)
- determination of specific micro-RNAs related to plaque vulnerability
- echocardiography (+ speckle tracking) for assessment of left ventricular function and size
- full characterization of PD (dental plaque/tartar, gingival retraction, gingival bleeding, etc.)
- microbiological determination of oral bacteria from the periodontal pockets
- non-invasive imaging by coronary angioCT for all the coronary tree and characterization of vulnerability markers and atherosclerosis severity, using surrogate imaging biomarkers such as calcium score, necrotic core, plaque burden, low density atheroma, positive remodeling, epicardial fat volume
- invasive imaging performed during invasive revascularization procedures, using intracoronary imaging techniques (OCT, IVUS) and quantification of invasive imaging biomarkers in culprit and non-culprit lesions, such as macrophage content, thickness of fibrous cap and necrotic core.
- atherectomy of coronary culprit atheromatous plaques (in the atherectomy sub-study), performed during the revascularization procedure when indicated, in selected cases, followed by histological examination of the samples collected in order to identify specific antigens related to oral microbiota in the atheromatous tissue of coronary vulnerable plaques.
Follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months after randomization, including assessment of clinical data, echocardiography and registration of MACE and adverse events.
In addition, complex imaging assessment using Angio CT will be performed at 2 years to assess atherosclerosis progression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATD - SG 01 | – | Diagnostic Test: cardiac imaging testsPatients with acute coronary syndrome in whom dental examination performed in the first 7 days after the index event revealed the presence of periodontal disease. They will undergo complex cardiac imaging tests to assess plaque vulnerability and severity of coronary artery disease. |
| ATD - SG 02 | – | Diagnostic Test: cardiac imaging testsPatients with acute coronary syndrome in whom dental examination performed in the first 7 days after the index event did not reveal the presence of periodontal disease. They will undergo complex cardiac imaging tests to assess plaque vulnerability and severity of coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndromes (unstable angina or NSTEMI), who undergo invasive coronary angiography +/- revascularization (according to local protocols).
Key inclusion criteria (3 listed)
- Patients aged at least 18 years;
- Patients who have signed the written informed consent;
- Patients with ACS (unstable angina or non-ST segment elevation myocardial infarction) occurring with maximum 7 days prior to enrollment
Key exclusion criteria (8 listed)
- Patient's refusal to participate in the study;
- Sensitivity to the contrast substance;
- Women of reproductive age who do not use contraceptive methods;
- Pregnant women;
- Any malignancy within the last 5 years;
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 |
|---|---|---|
| cardiac imaging testscardiac computed tomography, echocardiography, intravascular ultrasound, optical coherence tomography | Diagnostic test | ATD - SG 01, ATD - SG 02 |
Primary outcome
The rate of major adverse cardiovascular events (MACE rates).
Time frame: 24 months
Cardiac death, need for target vessel revascularization (with target vessel defined as the vessel with a vulnerable plaque), or reinfarction.
3 secondary outcomes
The rate of progression of vulnerability degree of non-culprit coronary plaques
Time frame: 24 months
The rate of progression of atheromatous burden and calcium scoring
Time frame: 24 months
The occurrence of left ventricular remodeling and post-infarction heart failure
Time frame: 24 months
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 2 Aug 2022.
- Individual participant dataSharing planned: Yes. IPD will be made available to other researchers from the same group and to other collaborating groups and can be used for further statistical sub-analysis
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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.
Theodora Benedek, Prof principal investigator
University of Medicine and Pharmacy Tirgu Mures, CardioMed Medical Center
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 Coronary Stenosis and Periodontal Diseases, run by Cardio Med Medical Center at 1 site in Romania.
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 8 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 2 Aug 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 Romania. 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?
The rate of major adverse cardiovascular events (MACE rates). (time frame: 24 months). 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 2 Aug 2022.