Individual progression of carotid intima media thickness as a surrogate for vascular risk (PROG-IMT): Rationale and design of a meta-analysis project.
Carotid intima media thickness (IMT) progression is increasingly used as a surrogate for vascular risk. This use is supported by data from a few clinical trials investigating statins, but established criteria of surrogacy are only partially fulfilled. To provide a valid basis for the use of IMT progression as a study end point, we are performing a 3-step meta-analysis project based on individual participant data. Objectives of the 3 successive stages are to investigate (1) whether IMT progression prospectively predicts myocardial infarction, stroke, or death in population-based samples; (2) whether it does so in prevalent disease cohorts; and (3) whether interventions affecting IMT progression predict a therapeutic effect on clinical end points. Recruitment strategies, inclusion criteria, and estimates of the expected numbers of eligible studies are presented along with a detailed analysis plan.
Lorenz
Matthias W
MW
Department of Neurology, University Hospital, Goethe-University, Frankfurt am Main, Germany. matthias.lorenz@em.uni-frankfurt.de
Bickel
Horst
H
Bots
Michiel L
ML
Breteler
Monique M B
MM
Catapano
Alberico L
AL
Desvarieux
Moise
M
Hedblad
Bo
B
Iglseder
Bernhard
B
Johnsen
Stein Harald
SH
Juraska
Michal
M
Kiechl
Stefan
S
Mathiesen
Ellisiv B
EB
Norata
Giuseppe D
GD
Grigore
Liliana
L
Polak
Joseph
J
Poppert
Holger
H
Rosvall
Maria
M
Rundek
Tatjana
T
Sacco
Ralph L
RL
Sander
Dirk
D
Sitzer
Matthias
M
Steinmetz
Helmuth
H
Stensland
Eva
E
Willeit
Johann
J
Witteman
Jacqueline
J
Yanez
David
D
Thompson
Simon G
SG
D002339:Carotid Arteries / Q000473:pathology*; D002340:Carotid Artery Diseases / Q000453:epidemiology; D006801:Humans; D015201:Meta-Analysis as Topic; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000453:epidemiology; D011237:Predictive Value of Tests; D012107:Research Design; D018570:Risk Assessment / Q000379:methods*; D020521:Stroke / Q000453:epidemiology; D017539:Tunica Intima / Q000473:pathology*