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

NCT03830944 | Completed

• 1 other identifier: CM0119-VIA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ST elevation myocardial infarction; Inflammatory Response; Coronary plaque vulnerability; myocardial viability

Outcome Measures

Primary Outcomes (1)

• Rate of post-infarction heart failure

  The primary outcome measure 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%).

  12 months

Secondary Outcomes (3)

• Rate of re-hospitalization

  12 months

• Rate of repeated revascularization

  12 months

• Rate of major adverse cardiovascular events

  12 months

Study Arms (2)

G1

Study subjects with STEMI and increased inflammatory response at 7 days after STEMI Interventions: * Blood sampling * transthoracic echocardiography * Late Gadolinium-Enhancement Cardiac Magnetic Resonance * Coronary Angio Computed Tomography

Diagnostic Test: Blood sampling; Diagnostic Test: transthoracic echocardiography; Diagnostic Test: Late Gadolinium-Enhancement Cardiac Magnetic Resonance; Diagnostic Test: Coronary Angio Computed Tomography

G2

Study subjects with STEMI and no increased inflammatory response at 7 days after STEMI Interventions: * Blood sampling * transthoracic echocardiography * Late Gadolinium-Enhancement Cardiac Magnetic Resonance * Coronary Angio Computed Tomography

Diagnostic Test: Blood sampling; Diagnostic Test: transthoracic echocardiography; Diagnostic Test: Late Gadolinium-Enhancement Cardiac Magnetic Resonance; Diagnostic Test: Coronary Angio Computed Tomography

Interventions

Blood sampling DIAGNOSTIC_TEST

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

G1; G2

transthoracic echocardiography DIAGNOSTIC_TEST

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

G1; G2

Late Gadolinium-Enhancement Cardiac Magnetic Resonance DIAGNOSTIC_TEST

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

G1; G2

Coronary Angio Computed Tomography DIAGNOSTIC_TEST

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

G1; G2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes patients from a single center with STEMI meeting inclusion and exclusion criteria and undergoing primary PCI.

You may qualify if:

• Patients with ST-segment elevation acute myocardial infarction treated by primary PCI within the first 12 hours after the onset of symptoms
• Ability to provide informed consent;
• Patients aged at least 18 years;

You may not qualify if:

• Patients with acute coronary syndrome in the last 30 days
• Unwillingness or incapacity to provide informed consent;
• Allergy to contrast media;
• Absolute or relative contraindications to magnetic resonance imaging
• Pregnancy or lactation;
• Women with childbearing potential in absence of any contraceptive treatment
• Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis;
• Active malignancy or malignancy within the last 5 year prior to enrollment;
• Conditions associated with an estimated life expectancy of under 1 year;

Sponsors & Collaborators

• Cardio Med Medical Center: lead
• George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures: collaborator
• Tîrgu Mureș Emergency Clinical County Hospital, Romania: collaborator

Study Sites (1)

Cardio Med Medical Center

Târgu Mureş, Mureș County, 540102, Romania

Location

MeSH Terms

Conditions

Heart Failure; ST Elevation Myocardial Infarction

Interventions

Blood Specimen Collection; Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Mirabela Morariu, MD

  University of Medicine, Pharmacy, Science and Technology of Tîrgu Mures, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2019
• First Posted: February 5, 2019
• Study Start: July 25, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The IPD sharing frame is starting 6 months after publication.

Locations

RO (1)