Multiomics and Imaging-based Assessment of Vulnerable Coronary Plaques in Acute Coronary Syndromes

NCT03391908 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-08-02

No results posted yet for this study

Summary

The aim of Multiplaque clinical study is to assess the vulnerability degree of the atheromatous plaques, before and after a myocardial infarction (MI), based on multiomics analysis, associated with invasive and non-invasive data. In this study, a multi-parametric model for risk prediction will be developed, for evaluation of the risk that is associated with the vulnerable coronary plaques in patients that have suffered an acute coronary syndrome.

In the study, evaluation of the imaging characteristics of these coronary plaques will be performed with the use of CT, OCT, IVUS and invasive angiography. We will study the correlation between plaque evolution and (1) the degree of vulnerability at baseline, (2) multiomics profile of the patients and (3) clinical evolution during follow-up.

Also, new techniques for evaluation of the functional significance of coronary stenoses will be studied and validated, such as calculation of the fractional flow reserve or determination of shear stress in areas that are localized within the near vicinity of the vulnerable coronary plaques.

Conditions

  • Coronary Stenosis
  • Acute Coronary Syndrome
  • Acute Myocardial Infarction
  • Atheromatous Plaques
  • Atherosclerosis
  • Unstable Angina
  • Non-ST Elevation Myocardial Infarction

Interventions

DIAGNOSTIC_TEST

cardiac imaging tests

Patients will undergo non-invasive Cardiac Computed Tomography for assessment of coronary plaques and myocardial perfusion, and invasive intracoronary imaging tests (coronary angiography, Intravascular ultrasound, optical coherence tomography and FFR). If imaging will reveal existence of a significant coronary plaque, a percutaneous coronary intervention (PCI - stenting) will be performed.

Sponsors & Collaborators

  • Cardio Med Medical Center

    lead INDUSTRY

Principal Investigators

  • Theodora Benedek, MD,Prof · University of Medicine and Pharmacy of Tirgu Mures, CardioMed Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2020-09-30
Completion
2021-01-31

Countries

  • Romania

Study Locations

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Entities

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 NCT03391908 on ClinicalTrials.gov