NCT03830944: VIABILITY

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

Completed Last updated 2 August 2022

What this trial tests

trial testing Blood sampling in Acute Myocardial Infarction in 150 participants. Completed in 1 March 2022.

Timeline

25 July 2019

Primary endpoint
1 March 2021

1 March 2022

Quick facts

Lead sponsor	Cardio Med Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	25 July 2019
Primary completion	1 March 2021
Estimated completion	1 March 2022
Sites	1 location across Romania

Drugs / interventions tested

• Blood sampling — full drug profile →
• transthoracic echocardiography
• Late Gadolinium-Enhancement Cardiac Magnetic Resonance
• Coronary Angio Computed Tomography

Conditions studied

• Acute Myocardial Infarction — all drugs for Acute Myocardial Infarction →
• Heart Failure — all drugs for Heart Failure →

Sponsor

Cardio Med Medical Center

Who can join

18 and older, any sex, with Acute Myocardial Infarction or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of inflammation-mediated response on pan-coronary plaque vulnerability, myocardial viability and ventricular remodeling in the postinfarction period - the VIABILITY study: Protocol for a non-randomized prospective clinical study.
   Morariu M, Hodas R, Benedek T, Benedek I, et al · · 2019 · cited 4× · PMID 31027064 · DOI 10.1097/md.0000000000015194