Should we Repair Ischemic Mitral Regurgitation? | NCT00443365

Studies
Should we Repair Ischemic Mitral Regurgitation?

NCT00443365

Sponsor

Medical University of Silesia

Status

Unknown status

Last Update Posted

May 30, 2008Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Coronary Disease
Mitral Valve Insufficiency

Interventions

Mitral valve repair

Countries

Poland

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 2008

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

Mar 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 2, 2007

First Submission Date that Met QC Criteria

Mar 2, 2007

First Posted Date

Mar 6, 2007Estimated

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 27, 2008

Last Update Posted Date

May 30, 2008Estimated

Name	Class
Ministry of Health, Poland	OTHER_GOV

Description Module

Brief Summary

The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Coronary Artery Bypass Grafting with no Mitral Valve intervention
2	Active Comparator	Coronary Artery Bypass Grafting + Mitral Annuloplasty	Procedure: Mitral valve repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mitral valve repair	Procedure	mitral valve annuloplasty	2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable coronary artery disease
Patient accepted for coronary artery bypass surgery
Ischemic mitral regurgitation

Exclusion Criteria:

Acute coronary syndrome within 30 days
Organic valvular heart disease
Need for other than CABG and mitral valve repair cardiac surgical procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marek A Deja, MD PhD	Contact	48-32-359-8542		mdeja@slam.katowice.pl

Overall Officials

Name	Affiliation	Role
Marek A Deja, MD PhD	Medical University of Silesia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Dept of Cardiac Surgery, Medical University of Silesia	Recruiting	Katowice		40-635	Poland

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058386	Mitral Valve Annuloplasty

Ancestor Terms

ID	Term
D058385	Cardiac Valve Annuloplasty
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided