Different Methods of Cardiac MRI in Assessment of Estimated Corrected Ejection Fraction in Valvular Heart Diseases

Sponsor
Assiut University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05808465
Collaborator
(none)
50
1
41.4
1.2

Study Details

Study Description

Brief Summary

Comparative study between Phase Contrast , Modified Simpson Rule and Myocardial Strain Analysis methods of Cardiac Magnetic Resonance Imaging in assessment of Corrected Estimated Ejection Fraction in Valvular Heart Disease To Evaluate the diagnostic accuracy of different methods of cardiac MRI to assess estimated corrected ejection fraction in valvular heart diseases.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Valvular heart diseases are common cardiovascular conditions that account for 10% to 20% of all cardiac surgical procedures.

    In routine clinical practice,left ventricular performance is one of the most important prognostic factors in valvular heart diseases,whether treated medically or surgically.It gives valuable information that may be useful in the selection of therapy or determination of the optimal time for intervention.

    Cardiovascular MR has grown to be a widely used clinical tool for evaluating cardiovascular disease,it is designed to assess cardiovascular morphology,ventricular function,myocardial perfusion,tissue characterization,flow quantification and coronary artery disease.Utilization of CMR for evaluation of valvular regurgitation has recently been recognized as part of the American Society of Echocardiography (ASE) and the Society of Cardiovascular Magnetic Resonance (SCMR) recommendations. In previous guidelines,CMR was only advocated in valvular disease in situations where echocardiographic evaluation was insufficient or inconclusive.However,with excellent spatial and temporal resolution,CMR may provide added benefits for valvular evaluation,including visualization of valve structure, direct measurements of flow,assessment of ventricular volumes, and quantification of regurgitant volumes and fractions .Among CMR techniques are:

    • Phase-contrast MRI a technique with which flow can be measured accurately with flexible spatial and temporal resolution .The severity of valvular disease can be assessed and quantified with Phase contrast MRI providing the ability to quantify peak velocities and flow across the valves.

    • Simpson rule a method to calculate cardiac global function parameters out of multiple single slices,quantifying volumetric indices of the heart directly from the 3 dimensional dataset; an ability that sets it apart from other modalities. End-Diastolic Volume,End-Systolic Volume,Stroke Volume,Ejection Fraction and Ventricular Mass can be obtained using Simpson rule making it able to determine these measurements in the right side as well as the left.

    • Myocardial Strain Analysis provides higher spatial resolution than echocardiography and is useful for the quantitative assessment of cardiac function.Measurement of left ventricular volume parameters such as ejection fraction, end diastolic volume, end systolic volume, stroke volume , cardiac output ,cardiac index and contractile function are possible in analysis using MRI.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparative Study Between Phase Contrast,Modified Simpson Rule and Myocardial Strain Analysis Methods of Cardiac MRI in Assessment of Estimated Corrected Ejection Fraction in Valvular Heart Disease.
    Actual Study Start Date :
    Mar 10, 2023
    Anticipated Primary Completion Date :
    Apr 20, 2026
    Anticipated Study Completion Date :
    Aug 20, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate diagnostic accuracy of different methods of Cardiac MRI to assess valvular heart disease [2 years 2024-2026]

      Cardiac MRI as a diagnostic tool in valvular heart diseases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • -All patients referred to radiology departement presented clinically with valvular heart disease.
    Exclusion Criteria:
    • 1- extremely obese patients. 2-patients with significant issues of claustrophobia. 3- patients with non-MR compatible implants. 4-patients with bad renal function.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Hazem A Zaid, Assiut University
    • Principal Investigator: Ahmed M Hakam, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Merna Sous Habib, Resident Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05808465
    Other Study ID Numbers:
    • Cardiac MRI
    First Posted:
    Apr 11, 2023
    Last Update Posted:
    Apr 14, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Merna Sous Habib, Resident Doctor, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 14, 2023