Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction (FITT-STEMI)

• mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality) [ Time Frame: five consecutive three month periods (quarters) ] [ Designated as safety issue: No ]
• Door to Balloon time [ Time Frame: five consecutive three-month periods (quarters) ] [ Designated as safety issue: No ]

The purpose of this study is to examine if formalized data assessment and systematic feedback improves treatment times (i.e. contact-to-balloon time and door-to-balloon time) in patients with myocardial infarction with ST-segment elevation (STEMI).

For many patients with myocardial infarction with ST-segment elevation (STEMI), the time from presentation to percutaneous coronary intervention (PCI) exceeds established goals. Formalized data feedback is one strategy proposed to reduce treatment time in STEMI-patients. The aim of this multicenter study is to evaluate whether systematic data analysis and feedback leads to shorter contact-to-balloon and door-to-balloon times and reduces mortality in different regional care networks serving patients with STEMI. The multicenter trial includes hospitals with primary percutaneous coronary intervention (PCI) capacity. Existing protocols encourage prompt transfer of patients with STEMI to the PCI center and emphasize minimizing time to treatment. In each participating center, all patients presenting with STEMI are enrolled. The study is conducted prospectively during five consecutive 3-month periods (quarters). Data collection is web-based and identical for the five quarters. For each center, time points from initial contact with the medical system to revascularization are assessed, analyzed and presented in an interactive session to hospital and emergency services staff. This formalized data feedback is performed at the end of each quarter.

Patients presenting during the first three-month period are included as the reference group. Data from patients with STEMI presenting during the next four quarters are presented in the same manner. Comparisons between the reference group and the next quarters will be made with the Gehan and Pearson χ2 tests.

• Scholz KH, Hilgers R, Ahlersmann D, Duwald H, Nitsche R, von Knobelsdorff G, Volger B, Möller K, Keating FK. Contact-to-balloon time and door-to-balloon time after initiation of a formalized data feedback in patients with acute ST-elevation myocardial infarction. Am J Cardiol. 2008 Jan 1;101(1):46-52. Epub 2007 Nov 19.
• Ting HH, Krumholz HM, Bradley EH, Cone DC, Curtis JP, Drew BJ, Field JM, French WJ, Gibler WB, Goff DC, Jacobs AK, Nallamothu BK, O'Connor RE, Schuur JD; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research, Emergency Cardiovascular Care Committee; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology. Implementation and integration of prehospital ECGs into systems of care for acute coronary syndrome: a scientific statement from the American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research, Emergency Cardiovascular Care Committee, Council on Cardiovascular Nursing, and Council on Clinical Cardiology. Circulation. 2008 Sep 2;118(10):1066-79. Epub 2008 Aug 13. No abstract available.
• Scholz KH, Maier SK, Jung J, Fleischmann C, Werner GS, Olbrich HG, Ahlersmann D, Keating FK, Jacobshagen C, Moehlis H, Hilgers R, Maier LS. Reduction in treatment times through formalized data feedback: results from a prospective multicenter study of ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Aug;5(8):848-57. doi: 10.1016/j.jcin.2012.04.012.

Inclusion Criteria:

• all patients who received a diagnosis of STEMI* and were transported to the cardiac catheterization laboratory of the primary PCI center with the intention to perform primary PCI.

  • STEMI definition:
• elevation of the ST-segments of greater than or equal to 0.1 mV in at least two contiguous limb leads or
• elevation of greater than or equal to 0.2 mV in at least 2 contiguous precordial leads or
• left bundle branch block in the presence of typical symptoms with a symptom duration of at least 30 minutes

Exclusion Criteria:

• duration of infarct symptoms greater than 24 hours