Back to resultsSpeckle Tracking for Timing of Surgical Operation in Severe Mitral Regurge
Primary Purpose
Rheumatic Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Replacment of mitral valve
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- rhuematic heart disease with severe mitral regurge
Exclusion Criteria:
- non rheumatic mitral regurge
Sites / Locations
- Assiut universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group a
Group b
Arm Description
Outcomes
Primary Outcome Measures
Timing of surgical operation in patients with chronic severe mitral regurge
Secondary Outcome Measures
Full Information
NCT ID
NCT03156972
First Posted
May 16, 2017
Last Updated
May 16, 2017
Sponsor
Mohammed mahmoud mohammed othman
1. Study Identification
Unique Protocol Identification Number
NCT03156972
Brief Title
Speckle Tracking for Timing of Surgical Operation in Severe Mitral Regurge
Official Title
Assessment of Rheumatic Heart Disease Patients With Chronic Severe Mitral Regurge by Speckle Tracking Echocardiography for Proper Timing of Surgical Operation.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohammed mahmoud mohammed othman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group a
Arm Type
Active Comparator
Arm Title
Group b
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Replacment of mitral valve
Intervention Description
Mitral valve replacment by prothsis
Primary Outcome Measure Information:
Title
Timing of surgical operation in patients with chronic severe mitral regurge
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
rhuematic heart disease with severe mitral regurge
Exclusion Criteria:
non rheumatic mitral regurge
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Dr Othman, Master
Phone
01002748383
Ext
002
Email
Ossman231@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Aly, Prof
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Mr Ahmed atef
Phone
01208083083
Ext
002
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Speckle Tracking for Timing of Surgical Operation in Severe Mitral Regurge
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