Phase Contrast in Valvular Heart Disease

September 12, 2018 updated by: Abdulrahman Emam Eldeen, Assiut University

Role of Phase Contrast Magnetic Resonance in Regurgitant Valvular Heart Diseases

The ability to quantify flow directly using through-plane phase contrast velocity mapping is a unique advantage of cardiovascular magnetic resonance and does not rely on the calculation from complex equations as echocardiography.

The aim s is to study the role of cardiac MRI in the evaluation of valvular heart disease through quantification of the impact of valvular lesions upon cardiac function by accurate estimation of the left ventricular ejection fraction

Study Overview

Status

Completed

Conditions

Detailed Description

Valvular heart disease is common and increases with age. In the past, valvular heart disease was typically caused by rheumatic heart disease, which remains a significant public health burden in developing countries. In industrialized nations, however, the rheumatic diseases has fallen substantially and valvular heart disease is now mainly degenerative in origin.

Valvular heart disease encompasses a number of common cardiovascular conditions that account for 10% to 20% of all cardiac surgical procedures.

Clinical examination is not a reliable guide to diagnosis or severity. This gap in the clinical valvular heart disease and the late presentation of many with severe disease emphasizes the importance of quantitative, high-quality cardiac imaging.

Imaging needs to assess: 1) valve morphology to determine the etiology and suitability for invasive intervention; 2) hemodynamic severity; 3) remodeling of the left ventricle and right ventricle; 4) involvement of the aorta and 5) the prediction of adverse cardiovascular events.

A number of imaging modalities are currently available to evaluate valvular heart disease in a comprehensive manner allowing correct assessment of both valve morphology and function. Doppler-echocardiography is the most frequently used tool for this purpose because it is cost-effective, widely available and, in the majority of the cases, provides sufficient information for clinical patient management and possible surgical planning.

For a long time, cardiac catheterization and invasive angiography have been regarded as the "gold standard". However, this invasive approach exposes patients to radiation and iodinated contrast media, carrying the non-negligible risk of life-threatening complications but nonetheless far from optimal especially regarding the precise quantification of valvular regurgitation.

Due to considerable improvements in hard- and software design in the last decade, magnetic resonance imaging has claimed its role as a central player in a large variety of cardiac diseases offering unique information about the mechanism of valve disease, quantifying the severity of disease, and discerning the consequences of the lesions including the effects on left ventricular volume, left ventricular systolic function, and left atrial volumes. Because of both its high accuracy and reproducibility, magnetic resonance imaging has become the preferred imaging modality in an increasing number of clinical trials. Also in the field of valvular heart disease, considerable progress has been achieved.

Today, cardiovascular magnetic resonance has a number of unique advantages over other imaging modalities. It provides a view of the entire heart without limitations from inadequate imaging windows or body habitus. Additionally, in some patients, information from clinical history and physical examination or other diagnostic tests may be discordant with echocardiographic findings where there is a significant clinical role for cardiovascular magnetic resonance. cardiovascular magnetic resonance also can obtain imaging data in any imaging plane prescribed by the scan operator, which makes it ideal for accurate investigation of all cardiac valves: aortic, mitral, pulmonic, and tricuspid. It can be considered an excellent adjunct to echocardiography for investigating patients with valve disease.

Study Type

Observational

Enrollment (Actual)

35

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, 71111
        • abdulrahman Emam

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted on 35 subjects including 25 patients with reversed cardiac hemodynamics and 10 age- and sex-matched healthy adult controls with no clinically or echocardiographically detected cardiac abnormalities. The 25 patients have been diagnosed clinically and by echocardiography to have valvular heart disease of different aetiologies (14 rheumatics, 5 ischemic, 6 non-ischemic cardiomyopathies).

Description

Inclusion Criteria:

  • Patients with clinically diagnosed valvular heart disease and confirmed by echocardiography

Exclusion Criteria:

  • Patients with known contraindication to MRI including the presence of paramagnetic
  • Surgical clips, or pacemakers
  • Severely ill patients
  • Claustrophobic or restless subjects
  • Patients with arrhythmia

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

Cohorts and Interventions

Group / Cohort
control group
10 normal healthy subjects are conducted for cardiac magnetic resonance imaging examination
case group
25 patients with valvular heart disease diagnosed clinically and by echocardiography are conducted for cardiac magnetic resonance imaging examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of ejection fraction
Time Frame: 1 day
measurement of ejection fraction via estimation of stroke volume divided by end diastolic volume of the left ventricle
1 day

Collaborators and Investigators

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

Sponsor

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)

July 1, 2017

Primary Completion (ACTUAL)

June 30, 2018

Study Completion (ACTUAL)

July 30, 2018

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (ACTUAL)

September 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-CMR-VHDs

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.

Clinical Trials on Valvular Heart Disease (Aortic and Mitral Valves)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe