70 likes | 211 Views
ASSENCE. A ssessment of cost-effectiveness of S everal S trategies of E arly diagnosis in patients with acute chest pain and N on C onclusive E lectrocardiogram. THE ASSENCE TRIAL Inclusion criteria. Unexplained chest pain in the last 24 hrs.
E N D
ASSENCE Assessment of cost-effectiveness of Several Strategies of Early diagnosis in patients with acute chest pain and Non Conclusive Electrocardiogram
THE ASSENCE TRIALInclusion criteria • Unexplained chest pain in the last 24 hrs. • EKG non-conclusive for acute myocardial ischemia • Age > 30 years • CK enzymes and cTnI negative after 6 hrs from symptom onset • Pts. able to perform an EKG exercise test
THE ASSENCE TRIALStudy Protocol Randomization (Within 6 hrs. from E.R. admission) NHP Questionnaire Conventional Observation Period Dobutamine-Atropine Stress Echo DASE - Immediate discharge DASE + Conventional treatment EKG EXERCISE TEST EET - Immediate discharge EET + Conventional treatment
THE ASSENCE TRIALEnd-Points • 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. • Costs.Length of hospitalization during index admission, repeated hospitalization, performed diagnostic procedures and treatments • Quality of life.Psychological well being
THE ASSENCE TRIALPresent situation • Sample size estimation = 186 pts x 3 • The trial started on May 1999 • 10 participating Istitutions from 6 countries: • Croatia • Greece • Iran • Italy • Lithuania • Turkey • Actual study population = 314 pts.
THE ASSENCE TRIALOrganization • Organized and founded by Istituto per la Ricerca Clinica Applicata e di Base (IRCAB) • Web-site www.insiel.net/ircab • E-mail ircab@insiel.net
THE ASSENCE TRIALResults 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