NCT03669666

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

September 12, 2018

Last Update Submit

September 12, 2018

Conditions

Keywords

valvular heart diseaseejection fraction

Outcome Measures

Primary Outcomes (1)

  • measurement of ejection fraction

    measurement of ejection fraction via estimation of stroke volume divided by end diastolic volume of the left ventricle

    1 day

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

abdulrahman Emam

Asyut, 71111, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 12831818BACKGROUND
  • Maganti 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.

    PMID: 20435842BACKGROUND
  • Chambers 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.

    PMID: 26977308BACKGROUND
  • Simpson IA, Sahn DJ. Quantification of valvular regurgitation by Doppler echocardiography. Circulation. 1991 Sep;84(3 Suppl):I188-92.

    PMID: 1884485BACKGROUND
  • Myerson 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.

    PMID: 22260363BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 13, 2018

Study Start

July 1, 2017

Primary Completion

June 30, 2018

Study Completion

July 30, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations