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

April 12, 2023 updated by: Merna Sous Habib, Assiut University

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Normally distributed data will be expressed in form of mean +/- SD and analysed by parametric tests while not normally will be expressed in form of median and analysed by non-parametric tests.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate diagnostic accuracy of different methods of Cardiac MRI to assess valvular heart disease
Time Frame: 2 years 2024-2026
Cardiac MRI as a diagnostic tool in valvular heart diseases
2 years 2024-2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Anticipated)

April 20, 2026

Study Completion (Anticipated)

August 20, 2026

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiac MRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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