PUMA - Pioneering the Use of Multivariate Diagnostics in Atherosclerosis
The MaGiCAD study was designed to obtain arterial blood samples from the femoral sheath at the time of cardiac catheterization. This had the advantage that the investigators were able to obtain a large volume of blood with the least inconvenience to the patient, allowing a whole range of genomic, proteomic, metabolomic and biochemical assays to be performed and compared. The next phase of Pronostics’ clinical research aims to assess our FingerPrint profiling technologies under conditions that are more appropriate for our commercial diagnostic tests. This second clinical study, named PUMA, was initiated in mid 2006, with recruitment planned to be completed in 15 months. PUMA’s two main objectives are as follows:
• To evaluate the diagnostic ability of the CADprint™ test to predict the outcome of angiography using venous blood samples from subjects attending cardiology outpatient clinics across the UK, and to provide support for the regulatory approval of the CADprint™ product.
• To evaluate the prognostic ability of a Pronostics’ FingerPrint profiling assays to identify patients who are likely to suffer a fatal MI using venous blood samples from subjects attending cardiology outpatient clinics across the UK.
PUMA will involve the recruitment of approximately 1,000 patients from hospital cardiology outpatient clinics, the target population for the commercial CADprint™ test. Unlike MaGiCAD, the trial is multi-centre and patients will be recruited from four centres in the UK (Addenbrookes Hospital Cambridge, St George’s Hospital London, the Norfolk & Norwich Hospital and Peterborough Hospital). These sites have been selected because they are (1) large enough to meet the very rapid projected recruitment rates and (2) diverse enough to ensure that the databank generated will be broadly applicable to unknown samples generated throughout the UK and European population (with sufficient numbers of ethnic minorities represented).
At each of the above hospitals, patients will be recruited from the outpatient clinics of participating consultant cardiologists. However, in order to maximise accrual rates and to ensure patients entering the study are a broad representation of all patients fitting the inclusion/exclusion criteria, it may be necessary to recruit from additional clinics within the same or neighbouring Strategic Health Authorities. Recruitment will continue until angiogram results are available for 1,000 subjects.
Trial Inclusion Criteria - The PUMA study group will be drawn from patients attending cardiology outpatient clinics for the first time, at one of the participating hospitals, and who are between 40 and 70 years of age.
Trial Exclusion Criteria - Patients for whom the clinic physician has excluded a diagnosis of CAD will be excluded from the study since such patients would not be subjected to the commercial CADprint™ product in a clinical environment. Patients who are unwilling or unable to give informed consent will also be excluded.
Blood samples will be collected from patients into tubes provided by Pronostics at the same time as blood is taken for all their routine biochemistry tests. The blood samples will be transferred to the local biochemistry labs where serum will be prepared. The serum will then be shipped to the central Pronostics laboratory for analysis using the CADprint™ assay.
Like MaGiCAD, PUMA’s results are planned to be of the stature to allow publication in top-ranked medical journals such as the Lancet or New England Journal of Medicine.
The PUMA Clincal trial is managed on behalf of Pronostics by TCP Innovations Ltd, Cambridge, UK.
