Abstract
Considering the low mortality rate related to cardiovascular diseases achieved by the currently available therapeutic options, proving the superiority of a new drug/intervention over standard treatment using mortality as the end point requires the inclusion of several thousands of patients in a prospective randomized clinical trial. The high costs involved in such trials represent a severe limitation for the development of new therapeutic strategies. At the same time, however, there is increasing acceptance that cardiac functional parameters, changes in which are directly related to the beneficial effect of an intervention, can be used as surrogate end points in small-sample size pilot-phase studies. This study design has been shown to be advantageous not only regarding cost-saving aspects but also for providing objective evaluation of the beneficial effect of a new treatment. In addition, the design helps in establishing the number of patients to be included in the definitive trial as well as determining the best dosage to be used. This review describes the available information supporting the use of nuclear cardiology imaging to reliably assess multiple cardiac function parameters constituting adequate surrogate end points for the assessment of therapeutic effects in several cardiovascular diseases. In addition, the technical aspects, feasibility and clear advantages of the use of nuclear cardiology core laboratories for centralized imaging processing/analysis in the context of multicenter clinical trials are also presented.
Original language | English |
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Pages (from-to) | 34-47 |
Number of pages | 14 |
Journal | HeartDrug |
Volume | 3 |
Issue number | 1 |
DOIs | |
State | Published - 2003 |
Keywords
- Cardiovascular disease
- Imaging
- Nuclear medicine
- Radioisotopes
- Scintigraphy