Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03395041
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2018-01-03
Brief Title:
Periodontal Disease Inflammation and Acute Coronary Syndromes
Sponsor:
Cardio Med Medical Center
Organization:
Cardio Med Medical Center
Study Overview
Official Title:
Periodontal Disease Inflammation and Atherosclerosis Progression in Patients With Acute Coronary Syndromes - the ATHERODENT Study
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHERODENT
Brief 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 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 andor 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
1 to study the correlation between PD and coronary plaque vulnerability
2 to assess the correlation between PD and severity of coronary atherosclerosis
3 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
1 recording of demographic and clinical data age gender personal history
2 determination of serum lipids blood counts glycemia urea creatinine liver enzymes
3 determination of the biomarkers expressing the severity of the acute coronary syndrome and heart damage hs-Troponin NT-proBNP
4 determination of serum levels inflammatory biomarkers and adhesion molecules at the moment of the index event hs-CRP matrix metalloprotease interleukin-6 VCAM ICAM
5 determination of specific micro-RNAs related to plaque vulnerability
6 echocardiography speckle tracking for assessment of left ventricular function and size
7 full characterization of PD dental plaquetartar gingival retraction gingival bleeding etc
8 microbiological determination of oral bacteria from the periodontal pockets
9 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
10 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
11 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
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
1 to study the correlation between PD and coronary plaque vulnerability
2 to assess the correlation between PD and severity of coronary atherosclerosis
3 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
1 recording of demographic and clinical data age gender personal history
2 determination of serum lipids blood counts glycemia urea creatinine liver enzymes
3 determination of the biomarkers expressing the severity of the acute coronary syndrome and heart damage hs-Troponin NT-proBNP
4 determination of serum levels inflammatory biomarkers and adhesion molecules at the moment of the index event hs-CRP matrix metalloprotease interleukin-6 VCAM ICAM
5 determination of specific micro-RNAs related to plaque vulnerability
6 echocardiography speckle tracking for assessment of left ventricular function and size
7 full characterization of PD dental plaquetartar gingival retraction gingival bleeding etc
8 microbiological determination of oral bacteria from the periodontal pockets
9 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
10 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
11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None