Speckle Tracking for Timing of Surgical Operation in Seve... | NCT03156972

Studies
Speckle Tracking for Timing of Surgical Operation in Severe Mitral Regurge

NCT03156972

Sponsor

Mohammed mahmoud mohammed othman

Status

Unknown status

Last Update Posted

May 17, 2017Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Rheumatic Heart Disease

Interventions

Replacment of mitral valve

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Apr 1, 2018Estimated

Completion Date

Aug 1, 2018Estimated

First Submitted Date

May 16, 2017

First Submission Date that Met QC Criteria

May 16, 2017

First Posted Date

May 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2017

Last Update Posted Date

May 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammed mahmoud mohammed othman, Assessment of rheumatic heart disease patients with chronic severe mitral regurge by Speckle Tracking Echocardiography for proper timing of surgical operation, Assiut UniversitySponsor-Investigator

Lead Sponsor

Mohammed mahmoud mohammed othmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group a	Active Comparator		Procedure: Replacment of mitral valve
Group b	Active Comparator		Procedure: Replacment of mitral valve

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Replacment of mitral valve	Procedure	Mitral valve replacment by prothsis	Group a Group b

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Timing of surgical operation in patients with chronic severe mitral regurge		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

rhuematic heart disease with severe mitral regurge

Exclusion Criteria:

non rheumatic mitral regurge

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammed Dr Othman, Master	Contact	01002748383	002	Ossman231@yahoo.com

Overall Officials

Name	Affiliation	Role
Mohammed Aly, Prof	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university	Recruiting	Asyut			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012214	Rheumatic Heart Disease

Ancestor Terms

ID	Term
D012213	Rheumatic Fever
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided