Condition category
Circulatory System
Date applied
02/07/2019
Date assigned
05/07/2019
Last edited
04/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://fmp.um5.ac.ma/

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

France

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

Publication citations

Additional files

Editorial Notes

03/07/2019: Trial’s existence confirmed by Prof. Mahdi Ait Houssa, Service de chirurgie cardiaque - Hôpital militaire d'instruction Mohammed V.