NCT03156972

Brief Summary

Rhumatic heart disease patients with mitral regurge untile know had adibat for timming of surgical interferance our study aim to solve this problme using a new technic in echocardiography called speckle tracking which is more accurate in estimating a changes occure to myocyte of the heart and so chosing the proper time for surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 16, 2017

Last Update Submit

May 16, 2017

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Timing of surgical operation in patients with chronic severe mitral regurge

    One year

Study Arms (2)

Group a

ACTIVE COMPARATOR
Procedure: Replacment of mitral valve

Group b

ACTIVE COMPARATOR
Procedure: Replacment of mitral valve

Interventions

Replacment of mitral valvePROCEDURE

Mitral valve replacment by prothsis

Group aGroup b

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • rhuematic heart disease with severe mitral regurge

You may not qualify if:

  • non rheumatic mitral regurge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular Diseases

Study Officials

  • Mohammed Aly, Prof

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Dr Othman, Master

CONTACT

01002748383Ossman231@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assessment of rheumatic heart disease patients with chronic severe mitral regurge by Speckle Tracking Echocardiography for proper timing of surgical operation

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 17, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2018

Study Completion

August 1, 2018

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)