Presenter Disc closure Information Jan Kornder MD FRC Jan Kornder MD, FRC CPC FACC CPC, FACC The following relationships s exist related to this presentation: Over the last 2 years: Advisory Boards: MODEST ( Less than n $5000 total): BMS, Lilly, Servier, Sanofi Aventis, an nd Astra Zeneca Speaker Honoraria: MODEST ( Less th han $10000 total) Boehringer-Ingelheim, Astra Zeneca, L Lilly, Pfizer, Sanofi Aventis, BMS Research: Roche, Astra Zeneca, Merck R h R h A t Z M k k S h i k-Schering, BMS, Sanofi BMS S fi All Honoraria and consulting fee es donated to charity
Wh t i What is a Registry? R i t ? A registry is a systemati A registry is a systemati ic recording of data on ic recording of data on patients with a specific c condition or device Registries do NOT test t the benefits of one drug or device compared to ano other or placebo, they record real life data of w what happens to pts with conditions or devices conditions or devices Registries can identify C CARE GAPS or provide hypothesis generating q questions, but do NOT answer specific treatme nt questions
Wh t i What is a cl l inical trial? i i l t i l? Biomedical or health-relate ed research studies in human beings that follow a a pre-defined protocol. Interventional studies are t Interventional studies are t those in which the those in which the research subjects are assig gned by the investigator to a treatment or other inte ervention, and their outco outcomes are measured. es a e easu ed Observational studies are t those in which individuals are observed and their outc comes are measured by the investigators. g
Wh t i Wh t i What is G What is G GRACE? G G GRACE? GRACE? GRACE? Launched in 1999, The G Launched in 1999, The G Launched in 1999, The G Launched in 1999, The G Global Registry of Acute Global Registry of Acute Global Registry of Acute Global Registry of Acute Coronary Events is an in Coronary Events is an in Coronary Events is an in Coronary Events is an in nternational database nternational database nternational database nternational database designed to track outco d d designed to track outco designed to track outco d d designed to track outco i i i i d t d t d t d t t t t t k k k k t t t t mes of patients mes of patients mes of patients mes of patients f f f f ti ti ti ti t t t t presenting with acute co presenting with acute co presenting with acute co presenting with acute co oronary syndromes, oronary syndromes, oronary syndromes, oronary syndromes, including myocardial inf including including myocardial inf including g g myocardial inf myocardial inf y y farction or unstable farction or unstable farction or unstable farction or unstable angina. angina. angina. angina. GRACE includes hospita GRACE includes hospita GRACE includes hospita GRACE includes hospita als in North America, als in North America, als in North America, als in North America, South America, Europe, South America Europe South America Europe South America, Europe, South America Europe South America Europe South America, Europe, South America, Europe, Asia, Australia and New Asia, Australia and New Asia, Australia and New Asia, Australia and New Asia Australia and New Asia Australia and New Asia Australia and New Asia Australia and New Zealand. Zealand. Zealand. Zealand.
Multinat Multinat Multinat Multinat ional Site Network ional Site Network ional Site Network ional Site Network Argentina Argentina 7 sites 7 sites Germany Germany 5 sites 5 sites Australia Australia 5 sites 5 sites Italy Italy 5 sites 5 sites Austria Austria 5 sites 5 sites New Zealand 2 sites New Zealand 2 sites Belgium Belgium g 6 sites 6 sites Poland Poland 6 sites 6 sites Brazil Brazil 7 sites 7 sites Spain Spain 3 sites 3 sites Canada Canada 5 sites 5 sites UK UK 4 sites 4 sites France France France France 7 sites 7 sites 7 sites 7 sites USA USA USA USA 19 sites 19 sites 19 sites 19 sites Adapted from The GRACE I The GRACE I Investigators Investigators Am Heart J Am Heart J 2001;141:190 2001;141:190- -9 Adapted from
What is G What is G What is G What is G GRACE? GRACE? GRACE? GRACE? Multinational, prospectiv Multinational, prospectiv Multinational, prospectiv Multinational, prospectiv ve registry of the entire ve registry of the entire ve registry of the entire ve registry of the entire spectrum of acute coron spectrum of acute coron spectrum of acute coron spectrum of acute coron spectrum of acute coron spectrum of acute coron spectrum of acute coron spectrum of acute coron nary syndromes (ACS) nary syndromes (ACS) nary syndromes (ACS) nary syndromes (ACS) nary syndromes (ACS) nary syndromes (ACS) nary syndromes (ACS) nary syndromes (ACS) Observational database Observational database Observational database Observational database of clinical management of clinical management of clinical management of clinical management practices and patient ou practices and patient ou practices and patient ou practices and patient ou utcomes in ACS utcomes in ACS utcomes in ACS utcomes in ACS 14 countries in Europe, 14 countries in Europe, 14 countries in Europe, 14 countries in Europe, North and South North and South North and South North and South America, Australia/New America, Australia/New America, Australia/New America, Australia/New Zealand Zealand Zealand Zealand First 10 consecutive cas First 10 consecutive cas First 10 consecutive cas First 10 consecutive cas First 10 consecutive cas First 10 consecutive cas First 10 consecutive cas First 10 consecutive cas ses per centre/month with ses per centre/month with ses per centre/month with ses per centre/month with ses per centre/month with ses per centre/month with ses per centre/month with ses per centre/month with qualifying symptoms plu qualifying symptoms plu qualifying symptoms qualifying symptoms us evidence of coronary us evidence of coronary evidence of coronary evidence of coronary plu plu us us artery disease artery disease artery disease artery disease The GRACE I The GRACE I nvestigators nvestigators Am Heart J Am Heart J 2001;141:190 2001;141:190- -9
Objec Objec ctives ctives Identify opportuniti Identify opportuniti Identify opportuniti Identify opportuniti ies to improve the ies to improve the ies to improve the ies to improve the quality of care for p q quality of care for p q quality of care for p q quality of care for p q y y y y p p patients with ACS patients with ACS p patients with ACS patients with ACS p p p Describe diagnosti Describe diagnosti Describe diagnosti Describe diagnosti c and treatment c and treatment c and treatment c and treatment strategies and hosp strategies and hosp strategies and hosp strategies and hosp strategies and hosp strategies and hosp strategies and hosp strategies and hosp pital and 6 month pital and 6 pital and 6 pital and 6-month pital and 6 pital and 6 pital and 6 month pital and 6-month month month month month associated outcom associated outcom associated outcom associated outcom mes mes mes mes Develop hypothese Develop hypothese Develop hypothese Develop hypothese Develop hypothese Develop hypothese Develop hypothese Develop hypothese es for future clinical es for future clinical es for future clinical es for future clinical es for future clinical es for future clinical es for future clinical es for future clinical research research research research
Patient Enr Patient Enr at e t at e t rolment + Follow- rolment + Follow o o e t e t o o o o -Up* Up Up Up* 80000 80000 70359 70359 Patients Enrolled 62936 62936 60000 60000 60000 60000 6 Month Follow-Up 57104 57104 55454 55454 50442 50442 46945 46945 ents ents 50000 50000 43117 43117 r of Patie r of Patie 38444 38444 40000 40000 35301 35301 28699 28699 27 27 7618 7618 30000 30000 30000 30000 Numbe Numbe 20303 20303 19453 19453 20000 20000 Canada (n=4,161 + 3558) Canada (n=4,161 + 3558) 13245 13245 11543 11543 6689 6689 10000 10000 2- -yr: yr: 6641 6641 0 2007 2007 1999 1999- -2000 2000 2001 2001 2002 2002 2003 2003 3 2004 2004 2005 2005 2006 2006 * As of Aug 26/08 * As of Aug 26/08
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