Valvular Heart Disease (Aortic and Mitral Valves)NCT03669666
Phase Contrast in Valvular Heart Disease
An observational study of Valvular Heart Disease (Aortic and Mitral Valves), run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Valvular Heart Disease (Aortic and Mitral Valves)
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 30 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Patients with clinically diagnosed valvular heart disease and confirmed by echocardiography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Keywords
- valvular heart disease, ejection fraction
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
measurement of ejection fraction
measurement of ejection fraction via estimation of stroke volume divided by end diastolic volume of the left ventricle
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start1 Jul 2017
- Primary completion30 Jun 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart Disease (Aortic and Mitral Valves)Studies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulrahman Emam Eldeen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669666
- Sponsor's protocol ID
- PC-CMR-VHDs
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
PubMed 12831818Maganti K, Rigolin VH, Sarano ME, Bonow RO. Valvular heart disease: diagnosis and management. Mayo Clin Proc. 2010 May;85(5):483-500. doi: 10.4065/mcp.2009.0706.
PubMed 20435842Chambers JB, Myerson SG, Rajani R, Morgan-Hughes GJ, Dweck MR. Multimodality imaging in heart valve disease. Open Heart. 2016 Mar 8;3(1):e000330. doi: 10.1136/openhrt-2015-000330. eCollection 2016.
PubMed 26977308Simpson IA, Sahn DJ. Quantification of valvular regurgitation by Doppler echocardiography. Circulation. 1991 Sep;84(3 Suppl):I188-92.
PubMed 1884485Myerson SG. Heart valve disease: investigation by cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2012 Jan 19;14(1):7. doi: 10.1186/1532-429X-14-7.
PubMed 22260363
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Phase Contrast Magnetic Resonance in Regurgitant Valvular Heart Diseases
- ClinicalTrials.gov ID
- NCT03669666
- Acronym / sponsor ID
- PC-CMR-VHDs
- Keywords
- valvular heart disease, ejection fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 13 Sep 2018 (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.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients with clinically diagnosed valvular heart disease and confirmed by echocardiography
Key exclusion criteria (5 listed)
- 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Background: PubMed 12831818Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
- Background: PubMed 20435842Maganti K, Rigolin VH, Sarano ME, Bonow RO. Valvular heart disease: diagnosis and management. Mayo Clin Proc. 2010 May;85(5):483-500. doi: 10.4065/mcp.2009.0706.
- Background: PubMed 26977308Chambers JB, Myerson SG, Rajani R, Morgan-Hughes GJ, Dweck MR. Multimodality imaging in heart valve disease. Open Heart. 2016 Mar 8;3(1):e000330. doi: 10.1136/openhrt-2015-000330. eCollection 2016.
- Background: PubMed 1884485Simpson IA, Sahn DJ. Quantification of valvular regurgitation by Doppler echocardiography. Circulation. 1991 Sep;84(3 Suppl):I188-92.
- Background: PubMed 22260363Myerson SG. Heart valve disease: investigation by cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2012 Jan 19;14(1):7. doi: 10.1186/1532-429X-14-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (Aortic and Mitral Valves), 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 5 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: finished, as of the sponsor's last update on 13 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
measurement of ejection fraction (time frame: 1 day). 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 NCT03669666, which also lists 5 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 13 Sep 2018.