title: The impact of processes of care on myocardial infarct size in patients with ST-segment elevation myocardial infarction: observations from the CRISP-AMI trial.
abstract: BACKGROUND
  Primary percutaneous coronary intervention (PCI) is the most common method of reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) in the United States. The intersection between processes of care and performance measures such as door-to-balloon (D2B) times and clinical trials evaluating novel therapies for STEMI has not been fully investigated.
  
  
  OBJECTIVE
  Processes of STEMI care, incorporating clinical trial enrollment and randomization, in patients undergoing reperfusion with primary PCI in the Counterpulsation Reduces Infarct Size Pre-Percutaneous Coronary Intervention Acute Myocardial Infarction trial (CRISP-AMI) will conform to current standards of care.
  
  
  METHODS
  Patients enrolled in CRISP-AMI were included in the current analysis. Processes of care during reperfusion were recorded prospectively and compared between groups.
  
  
  RESULTS
  A total of 337 patients with anterior STEMI without cardiogenic shock were randomized in CRISP-AMI. Complete processes-of-care data were available for 303 patients (89.9%). In this cohort, 68.0% of patients underwent reperfusion within 90 minutes of hospital contact, and the median D2B time was 71 minutes. Time from hospital contact to informed consent was significantly different across different regions (North America, 45 minutes; India, 35 minutes; Europe, 20 minutes).
  
  
  CONCLUSIONS
  In CRISP-AMI, reperfusion was accomplished in a timely fashion while incorporating informed consent and randomization among patients with anterior myocardial infarction. Further study of patients' comprehension and preferences during the informed-consent process in STEMI patients is warranted so that innovative drugs and devices can be safely and ethically tested.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: W Schuyler
authors.initials: WS
authors.lastname: Jones
authors.forename: Robert M
authors.initials: RM
authors.lastname: Clare
authors.forename: Karen
authors.initials: K
authors.lastname: Chiswell
authors.forename: Divaka
authors.initials: D
authors.lastname: Perera
authors.forename: John K
authors.initials: JK
authors.lastname: French
authors.forename: A Sreenivas
authors.initials: AS
authors.lastname: Kumar
authors.forename: Jonathan
authors.initials: J
authors.lastname: Blaxill
authors.forename: Nico
authors.initials: N
authors.lastname: Pijls
authors.forename: James
authors.initials: J
authors.lastname: Mills
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.forename: Manesh R
authors.initials: MR
authors.lastname: Patel
mesh_terms: D000368:Aged; D001794:Blood Pressure; D017023:Coronary Angiography; D003326:Coronary Circulation; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000175:diagnosis* / Q000628:therapy*; D015425:Myocardial Reperfusion; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies