ASSENCE Assessment of cost-effectiveness of Several Strategies of Early diagnosis in patients with acute chest pain and Non Conclusive Electrocardiogram

THE ASSENCE TRIAL Inclusion criteria Unexplained chest pain in the last 24 hrs. Unexplained chest pain in the last 24 hrs. EKG non-conclusive for acute myocardial ischemia EKG non-conclusive for acute myocardial ischemia Age > 30 years Age > 30 years CK enzymes and cTnI negative after 6 hrs from symptom onset CK enzymes and cTnI negative after 6 hrs from symptom onset Pts. able to perform an EKG exercise test Pts. able to perform an EKG exercise test

THE ASSENCE TRIAL Study Protocol Randomization (Within 6 hrs. from E.R. admission) NHP Questionnaire Conventional Observation Period EKG EXERCISE TEST EKG EXERCISE TEST EET - Immediate discharge EET + Conventional treatment Dobutamine-Atropine Stress Echo DASE - Immediate discharge DASE + Conventional treatment

THE ASSENCE TRIAL End-Points In-hospital events. PTCA, CABG, AMI, cardiac death, cardiogenic shock or cardiac arrest, VT requiring defibrillation, VF.In-hospital events. PTCA, CABG, AMI, cardiac death, cardiogenic shock or cardiac arrest, VT requiring defibrillation, VF. Follow-up (1 wk, 1 mo., 2 mo.) events. The above events and occurrence of typical angina, re-hospitalization for chest- pain, re-hospitalization for angina, definite unstable angina.Follow-up (1 wk, 1 mo., 2 mo.) events. The above events and occurrence of typical angina, re-hospitalization for chest- pain, re-hospitalization for angina, definite unstable angina. Costs. Length of hospitalization during index admission, repeated hospitalization, performed diagnostic procedures and treatmentsCosts. Length of hospitalization during index admission, repeated hospitalization, performed diagnostic procedures and treatments Quality of life. Psychological well beingQuality of life. Psychological well being

THE ASSENCE TRIAL Present situation Sample size estimation = 186 pts x 3Sample size estimation = 186 pts x 3 The trial started on May 1999The trial started on May participating Istitutions from 6 countries:10 participating Istitutions from 6 countries: –Croatia –Greece –Iran –Italy –Lithuania –Turkey Actual study population = 314 pts.Actual study population = 314 pts.

THE ASSENCE TRIAL Organization Organized and founded by Istituto per la Ricerca Clinica Applicata e di Base (IRCAB) Web-site

THE ASSENCE TRIAL Results Since main results of the ASSENCE Trial have not yet been published they may not be divulgated. Luigi P. Badano, MD, Fellow ANMCO, FESC ASSENCE Principal Investigator