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Systemic, Pancoronary and Local Coronary Vulnerability

NCT03606330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-08-02

No results posted yet for this study

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.

Conditions

  • Coronary Stenosis
  • Acute Coronary Syndrome
  • Acute Myocardial Infarction
  • Atheromatous Plaques
  • Atheroscleroses, Coronary
  • Non-ST Elevation Myocardial Infarction (nSTEMI)

Interventions

DIAGNOSTIC_TEST

Cardiac imaging tests

* 2D transthoracic echocardiography * 128-multislice CT coronary angiography with the evaluation of: epicardial fat volume, plaque burden, total and local calcium score, markers for lesion severity; morphological plaque characteristics; plaque components evaluated via volumetric and planimetric units; markers of plaque vulnerability (necrotic core, low attenuation plaque, spotty calcification, napkin ring sign, positive remodeling). * Shear stress evaluation via computational fluid dynamics. * Intracoronary imaging techniques: IVUS and OCT.

DIAGNOSTIC_TEST

Venous blood sample collection

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

Sponsors & Collaborators

  • University of Targu Mures, Romania

    collaborator OTHER

  • University Hospital of Targu Mures, Romania

    collaborator OTHER

  • Cardio Med Medical Center

    lead INDUSTRY

Principal Investigators

  • Theodora Benedek, Professor · Cardio Med Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2019-10-22
Completion
2022-03-01

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606330 on ClinicalTrials.gov