Valvular Heart Disease Stenosis and RegurgitationNCT05808465
Different Methods of Cardiac MRI in Assessment of Estimated Corrected Ejection Fraction in Valvular Heart Diseases
An observational study of Valvular Heart Disease Stenosis and Regurgitation, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Valvular Heart Disease Stenosis and Regurgitation
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2023to 20 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 80 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- -All patients referred to radiology departement presented clinically with valvular heart disease.
Who cannot join
- 1- extremely obese patients. 2-patients with significant issues of claustrophobia. 3- patients with non-MR compatible implants. 4-patients with bad renal function.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Keywords
- Cardiac MRI methods
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate diagnostic accuracy of different methods of Cardiac MRI to assess valvular heart disease
Cardiac MRI as a diagnostic tool in valvular heart diseases
Measured: 2 years 2024-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start10 Mar 2023
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart Disease Stenosis and RegurgitationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Sous Habib, Assiut University
- Investigators
- Hazem A Zaid, Principal investigator, Assiut UniversityAhmed M Hakam, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808465
- Sponsor's protocol ID
- Cardiac MRI
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uretsky S, Wolff SD. Cardiovascular Magnetic Resonance in Valvular Heart Disease-Related Heart Failure. Heart Fail Clin. 2021 Jan;17(1):103-108. doi: 10.1016/j.hfc.2020.09.002.
PubMed 33220879Blanken CPS, Farag ES, Boekholdt SM, Leiner T, Kluin J, Nederveen AJ, van Ooij P, Planken RN. Advanced cardiac MRI techniques for evaluation of left-sided valvular heart disease. J Magn Reson Imaging. 2018 Aug;48(2):318-329. doi: 10.1002/jmri.26204.
PubMed 30134000
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05808465
- Acronym / sponsor ID
- Cardiac MRI
- Keywords
- Cardiac MRI methods
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -All patients referred to radiology departement presented clinically with valvular heart disease.
Key exclusion criteria (1 listed)
- 1- extremely obese patients. 2-patients with significant issues of claustrophobia. 3- patients with non-MR compatible implants. 4-patients with bad renal function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Background: PubMed 33220879Uretsky S, Wolff SD. Cardiovascular Magnetic Resonance in Valvular Heart Disease-Related Heart Failure. Heart Fail Clin. 2021 Jan;17(1):103-108. doi: 10.1016/j.hfc.2020.09.002.
- Background: PubMed 30134000Blanken CPS, Farag ES, Boekholdt SM, Leiner T, Kluin J, Nederveen AJ, van Ooij P, Planken RN. Advanced cardiac MRI techniques for evaluation of left-sided valvular heart disease. J Magn Reson Imaging. 2018 Aug;48(2):318-329. doi: 10.1002/jmri.26204.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazem A Zaid principal investigator
Assiut University
Ahmed M Hakam principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease Stenosis and Regurgitation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate diagnostic accuracy of different methods of Cardiac MRI to assess valvular heart disease (time frame: 2 years 2024-2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05808465, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.