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.: PACTR201911744449406 Date of Approval: 21/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Endarterectomy of Extensively Diseased Left Anterior Descending Artery: Does Previous Percutaneous Coronary Artery Intervention Affect Early and Mid-Term outcomes?
Official scientific title Does Previous Percutaneous Coronary Artery Intervention Affect Early and Mid-Term outcomes?
Brief summary describing the background and objectives of the trial Our study aims to search the impact of stent implantation on endarterectomy, and if it affecets the procedure and the complications after CABG. Additionally, the 5-year survival rate affection
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Circulatory System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 10/01/2012
Actual trial start date 20/03/2012
Anticipated date of last follow up 10/01/2018
Actual Last follow-up date 10/01/2020
Anticipated target sample size (number of participants) 350
Actual target sample size (number of participants) 241
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no previous PCI (endarterectomy patients without a history of previous stents) 5 years survival follow up in and outside te hospital 175 Active-Treatment of Control Group
Experimental Group endartrectomy with single LAD STENT in and outpatient complication 5 year survival morbity and moratlity outcome 94
Experimental Group multiple LAD stents follow up 5 years survival in and outpatients morbidity and mortality 72
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All CABG patients with LAD disease non LAD disease Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 75 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 10/01/2012 ethical commitee of ain sams university
Ethics Committee Address
Street address City Postal code Country
abbaseya cairo 11535 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome impact of stent implantation on endarterectomy in hospital till 5 years
Secondary Outcome 5 years survival till 5 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
academy of cardiothoracic surgery abbaseya cairo 11535 Egypt
king abdel aziz cardiac centre riyadh riyadh 11543 Saudi Arabia
FUNDING SOURCES
Name of source Street address City Postal code Country
ain shams university abbasya cairo 11535 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Gamal Adel Abdelhameed abbaseya cairo 11535 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gamal adel gem6082@yahoo.com 00201005006082 abbaseya
City Postal code Country Position/Affiliation
cairo 11535 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries waleed ismai Dr.waleed.ismail@gmail.com 010050006082 abbaseya
City Postal code Country Position/Affiliation
cairo 11539 Egypt lecturer of cadiac surgery
Role Name Email Phone Street address
Scientific Enquiries mohamed elsaid mohammedelsaid@gmail.com 0020122584563 riad
City Postal code Country Position/Affiliation
riyadh 11543 Saudi Arabia consultant of cardiac surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all details of the participants are available and their follow up sheets and investigations are available Informed Consent Form,Statistical Analysis Plan 6months corresponding author is available for inquiries and data publication within scientific discussion matters
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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