The World Health Organizaion (WHO) predicts that cardiovascular diseases would be the leading cause of morbidity and mortality in the developing countries by the year 20201,2,3,4. There is high prevelance of certain risk factors in the Arabian Gulf countries. Studies indicate a high prevalence rate of type 2 diabetes among adult populations (15-18%), Obesity, and smoking5,6,7,8,9. Therefore, it would sound reasonable to assume that the Arabian Gulf Region of the Middle East is at real risk of an epidemic of coronary artery disease (CAD). One form of CAD is acute coronary syndromes (ACS). Individual Gulf countries have their own established hospital or country registries of ACS. However, they lack uniformity and the big numbers needed to make conclusions from such registries meaningful. Therofore, the Gulf Heart Association (GHA) embarked on a big project to document ACS in the Gulf countries in a uniform fashion.
What will be presented here is a brief description of the Registry, what has been carried out so far and a brief look at some of the preliminary results.

Description of the Registry

The GHA Governing Board formed an ACS Committee on September 22, 2005, while meeting in Dubai, UAE. The main task of the Committee was to establish an ACS Registry. The GHA ACS Committee held its first meeting in Doha, Qatar on December 29, 2005 to critically undertake a major review of the draft protocol. The protocol was later reviewed and ratified by the GHA Governing Board on April 8, 2006 in Manama, Kingdom of Bahrain. The GHA ACS Committee formed an administrative infrastructure to insure the proper implementation of this Registry. It was named Gulf Registry of Acute Coronary Events, under the acronym “Gulf RACE”. Two stand-alone investigators meetings were held in preparation for the implementation of the Registry. The first one was held in Dubai on April 13, 2006 for the Oman and UAE investigators. The second meeting was held in Kuwait on April 20, 2006 for the Kuwait, Bahrain and Qatar investigators. The Case Report Form (CRF) and the protocol underwent final changes after both meetings.
A one-month pilot phase started on May 8, 2006. After the pilot phase, data were reviewed and further changes to the CRF were carried out. The second phase (5 months) started on January 15, 2007. The results of the pilot phase were published in the Saudi Medical Journal10.

Description of the Methodology

Gulf RACE is a prospective, multinational, muticentre survey of consecutive patients hospitalized with the final diagnosis of ACS in six Arabian Peninsula/Gulf countries over a period of six month. An attempt was made to include everyone with the final diagnosis of ACS, and there were no exclusion criteria. The study received ethical approval from the institutional ethical bodies in all participating countries. Of 74 medical centres invited to participate in the registry, 65 confirmed their participation and enrolled patients according to the survey inclusion criteria. In Bahrain, Kuwait and Qatar, all hospitals that admit patients with ACS participated in the survey, while in Oman, UAE and Yemen, most hospitals (covering at least 85% of the population) participated. Each participating hospital completed a questionnaire giving a description of the medical centre.
Diagnosis of the different types of ACS and definitions of data variables were based on the American College of Cardiology (ACC) clinical data standards, published in December 200111. These definitions are based on clinical presentations, electrocardiogram (ECG) findings and cardiac biomarkers. The biomarkers were measured locally at each hospital’s laboratory using its own assays and reference ranges. Data collected included patients’ demographics, past medical history, provisional diagnosis on admission and final discharge diagnosis, clinical features at hospital presentation, ECG findings, laboratory investigations, early in-hospital (administered within 24 hours of admission) and discharge medications, use of cardiac procedures and interventions, in-hospital outcomes and in-hospital mortality. All management decisions were at the discretion of the treating physician.
A national coordinator was assigned to each country to oversee the implementation of the survey protocol. A chief site officer was assigned to each site to maintain a log book of all suspected ACS admissions and to oversee the enrolment and completeness of the case report form (CRF) at his/her site. All national coordinators and chief site officers received full training involving a review of the survey protocol and methods for filling the CRF, which contained 231 fields. In addition to the formal training, a PowerPoint presentation of the protocol and CRF was created for the purpose of these meetings. This presentation was distributed to the national coordinators, chief site officers and site officers for their future reference. The site officers identified consecutive patients at the time of hospital admission and collected data prospectively on a standardized CRF. Filling of the CRF was initiated once an admission with a provisional diagnosis of ACS was made. If during hospital follow up a patient was found not to be an ACS case, then that patient and CRF were not included in the survey. Once CRFs were filled, they were checked for completeness by the designated chief site officer at each site. Then they were sent to a clinical research organization, where they were edited for missing data, inconsistencies and outliers. Site visits were carried out in all countries. Ten percent of CRFs and source documents were inspected. In Kuwait, Bahrain and Qatar, all sites were audited. In Oman, UAE and Yemen, the number of sites audited varied from 20% to 30%. The purpose of the site audits was to verify the data collected in the CRFs against the source documents. They were not intended to validate the accuracy of the discharge diagnosis by the attending physician.

Some Preliminary Results

The overall ACS population was characterized by relatively young age (mean 56.4 12.5 years) and high rates of diabetes (40.9%) and tobacco use (43.9%), Table 1. This high rate of diabetes was reflected by high rate of aspirin use at the time of admission (41.5%). The inhospital mortality was relatively low (3.8%).
Citizens had distinctly different characteristics from expatriates, Table 2. These differences included older age, more females, higher prevelance of CAD, different types of myocardial infarction, and double the incidence of inhospital mortality.
Diabetics in the Registry had different characteristics and higher inhospital mortality compared to non diabetics, Table 3. Diabetics were significantly older, and had more history of CAD and more non ST-segment elevation myocardial infarction.

Concluding remarks

Gulf RACE is the first ever unified ACS registry of its kind in the Middle East. It, simultaneously, involved 6 countries. For the first time, the results from Gulf RACE are providing us a window to the populations we are treating. Although one expects ACS pathology and pathophysiology across the world to be similar, other features may not be similar. These other elements include different populations with different ages and risk fatcors, etc.
We have had the opportunity to look at the preliminary data from Gulf RACE. So far, we can say that we have several important points of difference between our populations and the populations in the literature (mostly western). These differences include affect characteristics and outcomes. It would be important to know whether these differences would translate into different practice pattern and patient management.
We will be examining several issues from Gulf RACE including our adherence to guidelines and whether all 6 countries treating ACS similarly and efficiently. Presentation of more results will take place at the upcoming annual meeting of the GHA in Yemen during April 9-11, 2008.

Acknowledgements: The GHA would like to thank Sanofi Aventis for their support of Gulf RACE. Sanofi Aventis has provided unconditional and unrestricted grant for the undertaking of Gulf RACE.

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