NCT06741709

Brief Summary

This study investigates the characteristics and prevalence of mitral annular disjunction in patients with mitral valve prolapse with severe mitral regurgitation (MR) at Assiut University Heart Hospital.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress66%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 14, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

October 24, 2024

Last Update Submit

December 15, 2024

Conditions

Keywords

Mitral annular disjunction

Outcome Measures

Primary Outcomes (1)

  • Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse

    Detect the prevalence of mitral annular disjunction in patients with mitral valve prolapse

    six months

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

30

You may qualify if:

  • All consecutive patients \> 18 years of age presenting to Assiut University Heart Hospital with MVP and more than moderate MR.

You may not qualify if:

  • Previous mitral valve surgery.
  • MVP due to infective endocarditis.
  • Moderate or more significant aortic stenosis, aortic regurgitation or mitral stenosis.
  • Congenital heart disease and poor image quality precluding accurate assessment of the mitral valve.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 71111, Egypt

Location

Related Publications (4)

  • Hussain N, Bhagia G, Doyle M, Rayarao G, Williams RB, Biederman RWW. Mitral annular disjunction; how accurate are we? A cardiovascular MRI study defining risk. Int J Cardiol Heart Vasc. 2023 Nov 9;49:101298. doi: 10.1016/j.ijcha.2023.101298. eCollection 2023 Dec.

    PMID: 38035256BACKGROUND
  • Tison GH, Abreau S, Barrios J, Lim LJ, Yang M, Crudo V, Shah DJ, Nguyen T, Hu G, Dixit S, Nah G, Arya F, Bibby D, Lee Y, Delling FN. Identifying Mitral Valve Prolapse at Risk for Arrhythmias and Fibrosis From Electrocardiograms Using Deep Learning. JACC Adv. 2023 Aug;2(6):100446. doi: 10.1016/j.jacadv.2023.100446. Epub 2023 Aug 5.

    PMID: 37936601BACKGROUND
  • Donal E, Galli E, Letourneau T. Need for expertise in mitral valve regurgitation. Open Heart. 2019 Apr 28;6(1):e001039. doi: 10.1136/openhrt-2019-001039. eCollection 2019. No abstract available.

    PMID: 31168391BACKGROUND
  • Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.

    PMID: 28314623BACKGROUND

MeSH Terms

Conditions

Mitral Valve ProlapseMitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve ProlapseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Kerolos R. Ayad, MA

CONTACT

Yousra M. Hamdy, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

October 24, 2024

First Posted

December 19, 2024

Study Start

February 14, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations