NCT05808465

Brief 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 corrected ejection fraction in valvular heart diseases.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress92%
Mar 2023Aug 2026

Study Start

First participant enrolled

March 10, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Expected
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

3.1 years

First QC Date

March 30, 2023

Last Update Submit

April 12, 2023

Conditions

Valvular Heart Disease Stenosis and Regurgitation

Keywords

Cardiac MRI methods

Outcome Measures

Primary Outcomes (1)

  • Evaluate diagnostic accuracy of different methods of Cardiac MRI to assess valvular heart disease

    Cardiac MRI as a diagnostic tool in valvular heart diseases

    2 years 2024-2026

Eligibility Criteria

Age2 Years - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All patients referred to radiology departement presented clinically with valvular heart disease.

You may not qualify if:

  • extremely obese patients. 2-patients with significant issues of claustrophobia. 3- patients with non-MR compatible implants. 4-patients with bad renal function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 33220879BACKGROUND

  • Blanken 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.

    PMID: 30134000BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Hazem A Zaid

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Ahmed M Hakam

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 11, 2023

Study Start

March 10, 2023

Primary Completion

April 20, 2026

Study Completion (Estimated)

August 20, 2026

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)