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CCTA Coronary Hemodynamics, Systemic Inflammation and Vulnerable Plaques (COHESIVE)

NCT05488249 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-05-16

No results posted yet for this study

Summary

Although there are numerous studies that have demonstrated the impact of systemic inflammation on coronary plaque vulnerability, there are few literature data regarding the influence of coronary plaque localization within the coronary tree (right and left coronary artery, proximal, mid-coronary and distal), on plaque composition, morphology and degree of vulnerability, in relation with systemic inflammation and coronary hemodynamics. The aim of this study is to identify: (1) the impact of plaque topography in different sites within the coronary tree (right versus left, proximal distal) on their vulnerability degree evaluated with CCTA; (2) the relationship between degree of plaque vulnerability, systemic inflammatory biomarkers and specific hemodynamic characteristics quantified by coronary shear stress computations. The study will include 100 patients with stable coronary artery disease for which data collection will be perform on: (1) Clinical, echocardiographic and ECG data; (2) cardiovascular risk assessment; (3) 128 slice CCTA evaluation of coronary tree anatomy, plaque morphology, composition and vulnerability degree; (4) systemic inflammation based on serum levels of hsCRP, IL-6, MMP-9, periostin, adhesion molecules (5) shear stress via coronary flow computational simulations.

Conditions

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.

DIAGNOSTIC_TEST

Venous blood sample collection

Venous blood sample collection during CCTA image acquisition for evaluation of serum levels of hsCRP, IL-6, matrix metalloproteases - MMP9, Adhesion molecules (VCAM, ICAM, e-selectin, p-selectin) periostin.

Sponsors & Collaborators

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

    collaborator OTHER

  • University Hospital of Targu Mures, Romania

    collaborator OTHER

  • Cardio Med Medical Center

    lead INDUSTRY

Principal Investigators

  • Diana Opincariu, MD, PhD · CardioMed Medical Center

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2023-08-31
Completion
2023-08-31

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

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 NCT05488249 on ClinicalTrials.gov