Gene therapy techniques are under development for many areas of medici
ne, including cardiovascular disease. Identifying appropriate gene tar
gets will require more detailed knowledge of the molecular pathophysio
logy of these disorders, and choosing appropriate vectors and delivery
systems will contribute significantly to the challenge of developing
this approach for clinical use. The concepts of toxicology and therape
utic drug monitoring will need to be broadened to account for the uniq
ue chemical, biological, and genetic characteristics of gene therapeut
ic agents. This review will provide an overview of strategy developmen
t, currently available vectors, and examples of their application to c
ardiovascular gene transfer. Considerations of the potential toxicitie
s associated with particular vectors and delivery systems, as well as
the types of genetic modifications possible, will provide some guideli
nes regarding appropriate monitoring of their clinical application.