• Cardiology Clinical Trials
• Coronary Artery Disease

The Prospective Observational Longitudinal Registry of Patients with Stable Coronary Artery Disease (CLARIFY) study is a large (n=31,040) international trial that is aimed at evaluating outcomes and long-term prognostic determinants in outpatients with stable coronary artery disease (CAD), including heart rate (HR), that adequately represent this contemporary population worldwide. Ronald Henry, MD, Regional Coordinator of the CLARIFY study, Trinidad and Tobago, discussed the significance of the CLARIFY trial as it applies to the Caribbean.

While there is evidence that HR may be a prognostic indicator for cardiovascular (CV) outcomes, it has not yet been incorporated into CV risk assessment or therapeutic guidelines [Fox K et al. Lancet 2008]. Therefore, the CLARIFY registry offers a unique perspective regarding the role of HR in the setting of stable CAD, and this study may provide robust data about the disease presentation, risk management, and therapeutic strategies that are associated with HR. The prevalence of CAD has declined in developed countries, but this decline is offset by its increase in developing countries [Allender S et al. British Heart Foundation 2007]. Thus, CLARIFY may offer solutions to help alleviate the disease burden in regions where CAD is increasing despite contemporary drug therapies, such as the Caribbean. Additionally, Caribbean involvement in this study allows for soft entry of the region into international CV studies while adding to the learning curve for regional networking. This involvement also fosters the alignment of clinical practices with regional or international guidelines.

Data will be collected at baseline and every 6 months over the course of 5 years. CLARIFY analyses will include demographic data; risk factors and lifestyle; medical history; physical examination and vital signs, including resting HR, measured by pulse palpation and standard 12-lead ECG; current symptoms; medications; and most recent laboratory (eg, fasting blood glucose, lipid panel) and CAD assessment measurements (eg, stress testing results, echocardiography, myocardial imaging), when available. This comprehensive analysis will provide important information on the demographic and clinical profiles of “real-world” outpatients with CAD. The HR data will potentially offer dynamic estimations of the changing patterns of HR management, disease presentation, and therapy and may help with the development of a reliable risk prediction tool that is based on HR. CLARIFY will improve knowledge about the contemporary CAD population and may help solidify the role of HR as a prognostic indicator. This study is ongoing, and results are expected in 2015.

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