Ignite Creation Date:
2024-05-06 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03606330
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2018-06-26
Brief Title:
Systemic Pancoronary and Local Coronary Vulnerability
Sponsor:
Cardio Med Medical Center
Organization:
Cardio Med Medical Center
Study Overview
Official Title:
Systemic Pancoronary and Local Plaque Vulnerability for Image-based Prediction of Acute Coronary Syndromes - the VIP Study
Status:
COMPLETED
Status Verified Date:
2019-12
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:
VIP
Brief Summary:
The aim of the VIP study is to investigate the impact of vulnerability markers inflammatory serum biomarkers for systemic vulnerability coronary shear stress and vulnerability mapping for pancoronary vulnerability and imaging-based plaque features for systemic vulnerability on the rate of major adverse cardiovascular events caused by progression of the non-culprit lesion in patients with acute ST or non-ST segment elevation myocardial infarction who undergo revascularization of the culprit lesion during the acute event Furthermore the study will evaluate the rate of progression of non-culprit lesions towards a higher degree of vulnerability based on coronary computed tomography angiographic assessment at 1 year after enrollment
Detailed Description:
The project is a prospective cohort mono-centric study which will be carried out in the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed
The project will include 100 subjects who present ST and non-ST segment elevation myocardial infarction at 30 days prior to study enrollment who underwent emergency revascularization of the culprit lesion Samples for systemic serum biomarkers for myocardial injury myocardial strain and enhanced systemic inflammation will be collected at the moment of the acute event All patients will undergo coronary CT angiography cardiac perfusion CT and intracoronary imaging procedures Intravascular ultrasound - IVUS Optical Coherence Tomography - OCT at the moment of enrollment in the study for complex assessment of non-culprit coronary lesions The endothelial coronary shear stress will be calculated with imaging post-processing techniques on the CT data acquired at baseline by using computational fluid dynamics
The study will be conducted over a period of 3 years in which patients will be examined at baseline and during several follow-up visits At the one-year follow-up the study subjects will undergo CT coronary angiography for re-evaluation of the non-culprit lesions in the prospects of analyzing the rate of plaque progression towards a higher degree of vulnerability At the end of the 3-year period patients will be assessed about the occurrence of major adverse cardiovascular events and the rate or revascularization for non-culprit lesions
Study objectives
Primary to investigate the association between systemic pancoronary and local vulnerability features of coronary plaques and the risk for major adverse cardiac events - MACE all-cause mortality cardiovascular death myocardial infarction repeated revascularization repeated hospitalizations for cardiovascular related incidents cerebrovascular events during a 3-year follow-up
Secondary to assess the rate of progression for the non-culprit lesions towards a higher degree of vulnerability as evaluated via coronary CT angiography at 1 year after enrollment in relation to systemic pancoronary and local vulnerability features at baseline
To identify the type of vulnerability systemic pancoronary or local with the highest impact on plaque progression and future MACE
Study Timeline
Baseline day 0
Obtain and document consent from participant on study consent form
Verify inclusionexclusion criteria
Obtain demographic information medical history medication history alcohol and tobacco use history
Record results of physical examinations and 12-lead ECG
Collect blood specimens
Imaging procedures transthoracic 2-D echocardiography 128-multisclice CT angiography cardiac perfusion CT IVUS OCT
Visit 1 month 1
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography
Visit 2 month 3
Telephone follow-up
Visit 3 month 6
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography
Visit 4 month 12
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography 128-multislice CT coronary angiography for evaluation of non-culprit lesion
End-point evaluation
Visit 5 month 15
Telephone follow-up
Visit 6 month 18
Telephone follow-up
Visit 7 month 24
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography
End-point evaluation
Visit 8 month 30
Telephone follow-up
Final study visit month 36
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography
End-point evaluation
Study procedures
Clinical examination medical history
12-lead ECG
2D transthoracic echocardiography with measurement of cardiac diameters volumes valvular function and regurgitation pressure gradients pericardial fat thickness pericardial effusion left ventricular global and regional function and ejection fraction
128-multislice CT coronary angiography with the evaluation of epicardial fat volume plaque burden total and local calcium score markers for lesion severity degree of stenosis lesion length lumen area and diameter minimum and maximum plaque thickness morphological plaque characteristics plaque related volumes plaque burden vascular indexes - remodeling and eccentricity index plaque components evaluated via volumetric and planimetric units necrotic core fibrofatty tissue fibrotic tissue dense calcium markers of plaque vulnerability necrotic core low attenuation plaque spotty calcification napkin ring sign positive remodeling
Shear stress evaluation of CT acquired images and computational fluid dynamics
Intracoronary imaging techniques IVUS and OCT with evaluation of plaque characteristics
Venous blood sample collection during the acute coronary event for evaluation of serum levels of hsCRP IL-6 matrixmetalloproteases MMP9 Adhesion molecules VCAM ICAM alfa tumour necrosis factor hs-cTnI NTproBNP
Data collection In a dedicated database that includes all patient information demographics medical history medication therapeutic procedures information derived from imaging techniques echocardiography CT angiography CT imaging post-processing and shear stress evaluation
The project will include 100 subjects who present ST and non-ST segment elevation myocardial infarction at 30 days prior to study enrollment who underwent emergency revascularization of the culprit lesion Samples for systemic serum biomarkers for myocardial injury myocardial strain and enhanced systemic inflammation will be collected at the moment of the acute event All patients will undergo coronary CT angiography cardiac perfusion CT and intracoronary imaging procedures Intravascular ultrasound - IVUS Optical Coherence Tomography - OCT at the moment of enrollment in the study for complex assessment of non-culprit coronary lesions The endothelial coronary shear stress will be calculated with imaging post-processing techniques on the CT data acquired at baseline by using computational fluid dynamics
The study will be conducted over a period of 3 years in which patients will be examined at baseline and during several follow-up visits At the one-year follow-up the study subjects will undergo CT coronary angiography for re-evaluation of the non-culprit lesions in the prospects of analyzing the rate of plaque progression towards a higher degree of vulnerability At the end of the 3-year period patients will be assessed about the occurrence of major adverse cardiovascular events and the rate or revascularization for non-culprit lesions
Study objectives
Primary to investigate the association between systemic pancoronary and local vulnerability features of coronary plaques and the risk for major adverse cardiac events - MACE all-cause mortality cardiovascular death myocardial infarction repeated revascularization repeated hospitalizations for cardiovascular related incidents cerebrovascular events during a 3-year follow-up
Secondary to assess the rate of progression for the non-culprit lesions towards a higher degree of vulnerability as evaluated via coronary CT angiography at 1 year after enrollment in relation to systemic pancoronary and local vulnerability features at baseline
To identify the type of vulnerability systemic pancoronary or local with the highest impact on plaque progression and future MACE
Study Timeline
Baseline day 0
Obtain and document consent from participant on study consent form
Verify inclusionexclusion criteria
Obtain demographic information medical history medication history alcohol and tobacco use history
Record results of physical examinations and 12-lead ECG
Collect blood specimens
Imaging procedures transthoracic 2-D echocardiography 128-multisclice CT angiography cardiac perfusion CT IVUS OCT
Visit 1 month 1
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography
Visit 2 month 3
Telephone follow-up
Visit 3 month 6
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography
Visit 4 month 12
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography 128-multislice CT coronary angiography for evaluation of non-culprit lesion
End-point evaluation
Visit 5 month 15
Telephone follow-up
Visit 6 month 18
Telephone follow-up
Visit 7 month 24
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography
End-point evaluation
Visit 8 month 30
Telephone follow-up
Final study visit month 36
Record results of physical examinations 12-lead ECG and medical history
Imaging procedures transthoracic 2-D echocardiography
End-point evaluation
Study procedures
Clinical examination medical history
12-lead ECG
2D transthoracic echocardiography with measurement of cardiac diameters volumes valvular function and regurgitation pressure gradients pericardial fat thickness pericardial effusion left ventricular global and regional function and ejection fraction
128-multislice CT coronary angiography with the evaluation of epicardial fat volume plaque burden total and local calcium score markers for lesion severity degree of stenosis lesion length lumen area and diameter minimum and maximum plaque thickness morphological plaque characteristics plaque related volumes plaque burden vascular indexes - remodeling and eccentricity index plaque components evaluated via volumetric and planimetric units necrotic core fibrofatty tissue fibrotic tissue dense calcium markers of plaque vulnerability necrotic core low attenuation plaque spotty calcification napkin ring sign positive remodeling
Shear stress evaluation of CT acquired images and computational fluid dynamics
Intracoronary imaging techniques IVUS and OCT with evaluation of plaque characteristics
Venous blood sample collection during the acute coronary event for evaluation of serum levels of hsCRP IL-6 matrixmetalloproteases MMP9 Adhesion molecules VCAM ICAM alfa tumour necrosis factor hs-cTnI NTproBNP
Data collection In a dedicated database that includes all patient information demographics medical history medication therapeutic procedures information derived from imaging techniques echocardiography CT angiography CT imaging post-processing and shear stress evaluation
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