Inflammation-mediated Coronary Plaque Vulnerability, Myocardial Viability and Ventricular Remodeling

Summary

VIABILITY study aims to investigate the link between systemic inflammation, pancoronary plaque vulnerability (referring to the plaque vulnerability within the entire coronary tree), myocardial viability and ventricular remodeling in patients who had suffered a recent ST-segment elevation acute myocardial infarction (STEMI). The level of systemic inflammation in the acute phase of the myocardial infarction and at 1 month will be assessed on the basis of serum levels of inflammatory biomarkers (hsCRP, matrix metalloproteinases, interleukin-6). Pancoronary plaque vulnerability will be assessed: (1) in the acute phase of the infarction, based on serum biomarkers known to be associated with increased plaque vulnerability, such as adhesion molecules (V-CAM or I-CAM) determined from the blood samples collected in the first day after STEMI; (2) at 1 month after infarction, based on computed tomographic angiography analysis of vulnerability features present in all coronary plaques. Myocardial viability and remodeling will be assessed based on: (1) 3D speckle tracking echocardiography associated with dobutamine infusion; (2) MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis and scar at the level of left atrium and left ventricle. At the same time, CT imaging features associated with systemic and local inflammation, such as global epicardial fat or local pericoronary epicardial fat will be quantified in order to investigate the impact of inflammatory-mediated plaque vulnerability on the extent of myocardial damage in acute myocardial infarction. All these parameters will be investigated in patients with successful primary revascularization performed in a timely manner for ST-segment elevation acute myocardial infarction, who will be divided into 2 groups: group 1 - patients who present persistence of an augmented inflammatory status defined as serum levels of hsCRP\>3.0 mg/dl at discharge from the hospital or at 7 days postinfarction (whichever comes first), and group 2 - patients with no persistence of augmented inflammatory status (hsCRP\<3.0 mg/dl).

The primary endpoint of the study will be represented by the rate of post-infarction heart failure development, defined as the rate of re-admission in the hospital for heart failure or by a significant decrease in the ejection fraction (\<45%).

The secondary endpoints of the study will be:

* rate of re-hospitalization
* rate of repeated revascularization
* rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)

Conditions

• Acute Myocardial Infarction
• Heart Failure

Interventions

DIAGNOSTIC_TEST

Blood sampling

Assessment of complete blood count, biochemistry, inflammatory biomarkers, adhesion molecules

DIAGNOSTIC_TEST

transthoracic echocardiography

Assessment of the ventricular anatomy, size, function, speckle tracking, myocardial strain, valvular function.

DIAGNOSTIC_TEST

Late Gadolinium-Enhancement Cardiac Magnetic Resonance

Assessment of the ventricular anatomy, function, viability, degree of fibrosis, quantification of infarct size, mass.

DIAGNOSTIC_TEST

Coronary Angio Computed Tomography

Assessment of coronary plaque anatomy, morphology, vulnerability features, quantification of epicardial adipose tissue

Sponsors & Collaborators

• George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

  collaborator OTHER

• Tîrgu Mureș Emergency Clinical County Hospital, Romania

  collaborator OTHER

• Cardio Med Medical Center

  lead INDUSTRY

Principal Investigators

• Mirabela Morariu, MD · University of Medicine, Pharmacy, Science and Technology of Tîrgu Mures, Romania

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-25

Primary Completion

2021-03-01

Completion

2022-03-01

Countries

• Romania

Study Locations