MaGiCAD – The “Metabonomic and Genomic Investigation of Coronary Artery Disease”
The MaGiCAD study began in 2001 and recruitment was completed during 2006. The trial was managed by TCP Innovations Ltd, Cambridge, UK and was carried out by the Translational Research Unit, Papworth Hospital, Cambridge, UK.
MaGiCAD was a large-scale clinical study in which 1,234 individuals undergoing diagnostic angiography at Papworth Hospital were recruited. The number of patients recruited was determined by examining the age, sex and artery status distributions of the subjects listed for diagnostic angiography. This process ensured that the final cohort contained at least 50 individuals of each sex in each of the five disease severity classification groups. Every study participant is being “flagged” on the UK’s NHSCR (National Health Service Central Register) and profiles from patients whose cause of death is myocardial infarction (MI) will be analysed using Pronostics’ pattern recognition methodology to assess whether UltraPlex™ FingerPrint profiling is capable of predicting the likelihood of a fatal MI.
MaGiCAD used tightly-defined research methodology to collect serum, plasma, urine and DNA samples, and in total, more than more than 1.5 million data elements were collected from the cohort. This depth of data will permit determination of the relative contribution of the immunological profile data to the diagnosis of heart disease and the comparison with well-established clinical risk factors such as LDL cholesterol levels.
As well as providing supporting evidence for CADprint™, and for the purposes of assessing Pronostics’ immunomic FingerPrint technology in general (i.e. not limited to the specific CADprint™ test, allowing future comparison with other implementations of the FingerPrint technology) MaGiCAD also provides an invaluable resource for the investigation of risk factors associated with the development of CAD, as well as progression to fatal or non-fatal myocardial infarction.
The final analysis of the MaGiCAD study when completed will have the necessary statistical power for publication in the highest regarded clinical journals, such as the Lancet or New England Journal of Medicine.
However, whilst MaGiCAD is a crucial component of the package of data that will convince clinicians to adopt Pronostics’ technology, it is, in itself, insufficient to obtain regulatory approval of the commercial CADprint™ multiplexed product. This stems from the recruitment of patients at the time of their angiography, and the collection of blood from the femoral catheter during the procedure. As a result, MaGiCAD cannot tell us whether application of the CADprint™ profiling test in the out-patient clinic, prior to any decision to perform an angiogram, could usefully predict the coronary artery disease status of the patient.
The CADprint™ commercial product requires a database of patient profiles collected under identical circumstances to those patients that would be most eligible for the commercial CADprint™ test i.e. patients attending cardiology outpatient clinics for the first time. This database must also have good sampling density across all sections of the population to whom the test could be applied. Pronostics has designed a new trial, a 1,000 patient study, PUMA, which meets these criteria and will provide all the necessary data for regulatory approval of the CADprint™ commercial product. Please see the PUMA web page for more details.
