Prognostic role of post-infarction C-reactive protein in patients undergoing implantation of cardioverter-defibrillators: design of the C-reactive protein Assessment after Myocardial Infarction to GUide Implantation of DEfibrillator (CAMI GUIDE) study.
BACKGROUND
Patients at risk of sudden cardiac death (SCD) after myocardial infarction (MI) can currently be offered effective means of prevention, such as implantable cardioverter-defibrillators (ICD). However, predictors of SCD able to identify those patients who are at higher risk are still lacking. Whether C-reactive protein (CRP), a serum inflammatory marker with established prognostic accuracy after MI, can also be a predictor of SCD is unclear.


METHODS
The CAMI GUIDE study is designed to evaluate the prognostic role of CRP in patients undergoing ICD implantation after MI according to MADIT II criteria (i.e. left ventricular ejection fraction<or=30%). CAMI GUIDE is a prospective observational study aimed at assessing the role of CRP in the risk-stratification of SCD after MI. CRP will be measured on the basis of a pre-specified cut-off value of 3 mg/l, before and 1 month after ICD implantation; clinical follow-up will last 24 months. The primary endpoint is the combined rate of SCD or fast ventricular tachycardia/ventricular fibrillation. Secondary endpoints will be total mortality, death due to acute coronary syndromes, death from pump failure, non-fatal MI, coronary revascularization, hospitalization for congestive heart failure or unstable angina and inappropriate ICD shocks. Twenty-four Italian centers will participate in enrollment of the 290 patients planned according to power analysis.


CONCLUSIONS
The CAMI GUIDE study will assess the predictive role of CRP in SCD in patients with previous MI undergoing ICD implantation. Its results will improve risk stratification, thereby enabling better-tailored and more cost-effective therapies to be undertaken in those patients whose need is greatest.
Bellocci
Fulvio
F
Institute of Cardiology, Catholic University, A. Gemelli Hospital, Rome, Italy.
Biasucci
Luigi M
LM
Gensini
Gian Franco
GF
Padeletti
Luigi
L
Raviele
Antonio
A
Santini
Massimo
M
Giubilato
Giovanna
G
Landolina
Maurizio
M
Biondi-Zoccai
Giuseppe
G
Raciti
Giovanni
G
Sassara
Massimo
M
Castro
Antonello
A
Kheir
Antoine
A
Crea
Filippo
F
D015415:Biomarkers / Q000097:blood; D002097:C-Reactive Protein / Q000378:metabolism*; D015331:Cohort Studies; D003627:Data Interpretation, Statistical; D016757:Death, Sudden, Cardiac / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D009203:Myocardial Infarction / Q000097:blood / Q000150:complications / Q000401:mortality / Q000628:therapy*; D018579:Patient Selection; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D018401:Sample Size; D017180:Tachycardia, Ventricular / Q000097:blood / Q000517:prevention & control; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000097:blood / Q000517:prevention & control
D015415:Biomarkers; D002097:C-Reactive Protein