Plain English Summary
Background and study aims
Coronary artery disease is the term that describes what happens when the heart's blood supply is blocked or interrupted by a build-up of fatty substances in the coronary arteries. Coronary artery bypass grafting (CABG) is also known as bypass surgery, a heart bypass, or coronary artery bypass surgery. Type 2 diabetes is a common condition that causes the level of sugar (glucose) in the blood to become too high.
Aims:
- Define the factors that can predict hospital mortality after coronary bypass surgery in patients with type 2 diabetes.
- Evaluate adverse heart and brain events that occur after surgery.
- Evaluate the risk of readmissions to hospital and the need for surgical or percutaneous myocardial revascularization.
- Calculate medium and long term mortality and identify its predictive factors.
Who can participate?
Patients at Mohammed V teaching military hospital, who have type 2 diabetes mellitus and have undergone a coronary bypass graft to treat coronary artery disease.
What does the study involve?
It concerns only the study of records and collection of data already stored in our local database with no impact on the patient's health and discrimination.
What are the possible benefits and risks of participating?
The study is performed after discharge of patients and does not concern a change of treatment or intervention or anesthesia. Patients participating in the study are not exposed to any risk of side or adverse effects.
Where is the study run from?
Cardiac surgery department - Mohammed V teaching military hospital, Rabat, Morocco.
When is the study starting and how long is it expected to run for?
January 2000 to January 2019.
Who is funding the study?
Université Mohammed V de Rabat, Morocco.
Who is the main contact?
Prof. Younes Moutakiallah
dryouns@hotmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Younes Moutakiallah
ORCID ID
http://orcid.org/0000-0001-5600-1246
Contact details
Service de chirurgie cardiaque - Hôpital militaire d'instruction Mohammed V
Faculté de Médecine et de Pharmacie de Rabat - Université Mohammed V
Rabat
10045
Morocco
+212 537714708
dryouns@hotmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
MOR76
Study information
Scientific title
Comparison of outcome of coronary artery bypass grafting in diabetic and non-diabetic patients: experience of an African center
Acronym
Study hypothesis
1. Is diabetes an element of poor prognosis in coronary surgery?
2. Can coronary surgery in diabetics be safely and effectively performed in low-volume centers in developing countries?
3. What are the predictors of in-hospital morbidity and mortality in diabetic coronary surgery in low-volume centers in developing countries?
Ethics approval
Approval pending from Comité d'éthique de Recherche Biomédicale (CERB) Faculté de Médecine et de Pharmacie de Rabat Université Mohammed V de Rabat (Rabat, Morocco, 10045; [+212] 0537773560; guedirak@yahoo.fr), ref:
Study design
Single-center retrospective observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
No participant information sheet available
Condition
Coronary artery bypass in diabetes type 2 patients
Intervention
This is a retrospective study, all patients were already operated on and discharged from the hospital. Data will be collected from the local database and processed without any therapeutic change or intervention.
Data from diabetic patients who underwent coronary artery bypass grafting surgery since 2000 are included. Treatment was according to the usual protocol of the cardiac surgery department and they were followed by our outpatient clinic system.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Gathered from patient records from time of operation to end of study:
1. Incidence of postoperative major cardiovascular and cerebral events (MACCE).
2. Incidence of re-hospitalizations, re-interventions and the need for revascularization.
3. The mortality in the medium and long term.
Secondary outcome measures
none
Overall trial start date
01/01/2000
Overall trial end date
01/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Coronary artery disease
2. Diabetes mellitus type 2
3. Coronary artery bypass graft
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
550
Participant exclusion criteria
1. Diabetes mellitus type 1
Recruitment start date
15/01/2019
Recruitment end date
10/05/2019
Locations
Countries of recruitment
Morocco
Trial participating centre
Cardiac surgery department - Mohammed V teaching military hospital
Hay Riyad
Rabat
10045
Morocco
Sponsor information
Organisation
Faculty of medicine and pharmacy of Rabat - Mohammed V university
Sponsor details
Hay Souissi
Rabat
10045
Morocco
+212 537 77 37 01
WebMaster@fmp.um5.ac.ma
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Université Mohammed V de Rabat
Alternative name(s)
Mohammed V University, University Mohammed V in Rabat, Mohammed V University in Rabat, Université Mohammed V à Rabat, Mohammed V University of Rabat, UM5
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Morocco
Results and Publications
Publication and dissemination plan
The study will be submitted for publication in a Biomed Central journal as soon as possible.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
01/08/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list