Nuclear Cardiology Core Laboratory: State of the Art

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.

Quantitative Analyse von SPECT-Datensätzen des Herzens

“…Die laborübergreifende Standardisierung der Mess-und Auswerteprotokolle, die die Grundlage vieler multizentrischer Studien bildet [24], wurde in erster Linie von der Gruppe um O'Connor und Gibbons vom Mayo Clinic Core Laboratory vorangetrieben. Typischerweise werden dabei Herzphantome mit variablen Defekteinsätzen in moderat anthropomorphen Thoraxmodellen an die teilnehmenden Zentren verschickt.…”

Nuclear Imaging to Evaluate Therapy in Cardiology

“…In this issue of the Journal, Simoes et al [1] have extensively discussed the need and requirements for these core laboratories.…”

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In the current issue of this Journal, Simoes et al [1] describe the value of myocardial perfusion imaging (using SPECT, and to a lesser extent PET) to evaluate different treatments. In addition, the authors discuss the use of core laboratories in nuclear cardiology.

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Quantification of myocardial perfusion in 3D SPECT images- stress/rest volume differences

“…This situation shows an illustration of different stressinduced manifestations of CAD, depending on the extent of disease. CAD is the leading cause of death in developed western world [2], [3].…”

“…Cardiac stress testing is a common approach for diagnosing myocardial ischemia with underlying CAD, in which physical exercise or pharmacologic agents artificially "stress" the heart and raise the oxygen demand, failing to meet which sets in myocardial ischemia are leading to LV dysfunction [1][2][3][4]; the resulting changes, in electrophysiology, structure, function, perfusion and/or metabolic activity of the LV myocardium, are analyzed.…”