Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03606330 |
Other study ID # |
CM0118-PLI-3 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 22, 2018 |
Est. completion date |
March 1, 2022 |
Study information
Verified date |
December 2019 |
Source |
Cardio Med Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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 inclusion/exclusion 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).