Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002640828 Date of Approval: 24/09/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title moderate ischemic mitral regurge
Official scientific title MODERATE ISCHEMIC MITRAL REGURGE: REVASCULARIZATION ALONE VERSUS REVASCULARIZATION AND MITRAL VALVE REPAIR
Brief summary describing the background and objectives of the trial Ischemic mitral regurgitation (IMR) is a common finding following myocardial infarction or ischemia. Management of moderate IMR is still a hot topic. Adding mitral valve repair (MVr) to coronary artery bypass grafting (CABG) is questionable.The goal of this study was to assess and compare short term clinical and echocardiographic results of moderate IMR treated by CABG alone versus another group of patients treated by CABG plus MVr.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,mitral valve disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2016
Actual trial start date 02/01/2016
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date 10/10/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomization by computer software Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group coronary artery bypass surgery surgical operative CABG 20 Active-Treatment of Control Group
Experimental Group coronary artery bypass surgery+mitral valve repair surgical operatve CABG+MVr 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with coronary artery disease indicated for CABG concomitant moderate ischemic mitral regurge. emergency ejection fraction less than 30 concomitant aortic surgery concomitant carotid surgery 45 Year(s) 72 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/04/2016 faculty of medicine ethical committee
Ethics Committee Address
Street address City Postal code Country
yassin abd elgaffar shebin el kom 23151 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome degree of mitral valve regurgitation one week three months six months
Secondary Outcome (NYHA) functional class 1 week 3 months 6 months
Secondary Outcome ejection fraction (EF) 1 week 3 months 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mahalla cardiac center khalid ibn alwaleed mahalla- garbia 25311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mahalla cardiac center khalid ibn alwaleed mahalla 23511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufia university gamal abd el naser shebin el kom 23151 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mahalla cardiac center khalid ibn alwaleed mahalla 23511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohammed El Hag Aly elhagalycts@gmail.com 002 01004459536 faculty of medicine
City Postal code Country Position/Affiliation
shebin el kom 23151 Egypt lecturer of cardiothoracic surgery
Role Name Email Phone Street address
Public Enquiries YASSER swaaf yasserofegypt@hotmail.com 002 01145333995 khalid ibn elwalid
City Postal code Country Position/Affiliation
mahalla 23511 Egypt specialist
Role Name Email Phone Street address
Scientific Enquiries mohammed El Hag Aly elhagalycts@gmail.com 002 01004459536 yassin abd el gaffar
City Postal code Country Position/Affiliation
shebin el kom 23151 Egypt lecturer of cardiothoracic surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information