- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03606330
Systemic, Pancoronary and Local Coronary Vulnerability (VIP)
Systemic, Pancoronary and Local Plaque Vulnerability for Image-based Prediction of Acute Coronary Syndromes - the VIP Study
Study Overview
Status
Conditions
Intervention / Treatment
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 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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Mures
-
Târgu-Mureş, Mures, Romania
- Cardio Med
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged over 18 years old that have signed the written informed consent;
- Patients with ST and non-ST segment elevation myocardial infarction (as stated in the Third Universal Definition of Myocardial Infarction) at 30 days prior to randomization;
Exclusion Criteria:
- unwillingness or incapacity to provide informed consent (and if consent of legal guardian or family is not available);
- acute myocardial infarction at the moment of randomization (as these patients are referred to the hospital for emergency invasive coronary angiography and revascularization)
- conditions that present an estimated life expectancy of under 5 years;
- acute renal failure or terminal stage chronic kidney disease;
- pregnancy or lactation and women of reproductive age who are not using any contraceptive method;
- allergy and history of allergic reactions to iodine contrast media;
- active malignancy or malignancy within the last 1 year prior to enrollment;
- patients who, in the opinion of the investigators are not compliant and will not present for study visits.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
VP-SG 01
Study subjects that present MACE at the 36 months follow-up
|
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
|
VP-SG 02
Study subjects that do not present MACE at the 36 months follow-up
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE rate - Major adverse cardiovascular events
Time Frame: 36 months
|
Acute coronary syndromes (unstable angina, ST and non-ST elevation myocardial infarction), emergency revascularization of non-culprit lesions, repeated hospitalizations for cardiovascular reasons, acute cerebrovascular event.
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity progression of non-culprit coronary lesions
Time Frame: 12 months
|
Reevaluation of the non-culprit lesions via 128-multislice CT coronary angiography with analysis of the degree of stenosis caused by the non-culprit lesion.
|
12 months
|
Progression rate of CT markers for coronary plaque vulnerability
Time Frame: 12 months
|
Reevaluation of the non-culprit lesions via 128-multislice CT coronary angiography with analysis of the number of CT markers for coronary plaque vulnerability (low attenuation plaque, spotty calcification, napkin ring sign, positive remodeling).
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Theodora Benedek, Professor, Cardio Med Medical Center
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Coronary Disease
- Myocardial Infarction
- Infarction
- Coronary Artery Disease
- Myocardial Ischemia
- Atherosclerosis
- Acute Coronary Syndrome
- Coronary Stenosis
- Plaque, Atherosclerotic
- Non-ST Elevated Myocardial Infarction
Other Study ID Numbers
- CM0118-PLI-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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