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Sponsors and Collaborators: |
St.Bernward Hospital ALKK: Arbeitsgemeinschaft Kardiologischer Krankenhausaerzte |
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Information provided by: | St.Bernward Hospital |
ClinicalTrials.gov Identifier: | NCT00794001 |
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).
Condition | Intervention |
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Myocardial Infarction |
Behavioral: Data analysis and Feedback |
Study Type: | Interventional |
Study Design: | Health Services Research, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction (FITT-STEMI): A Multicenter Trial Analyzing the Effects of Systematic Data Feedback on Treatment Quality and Survival Rates. |
Estimated Enrollment: | 5000 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Data Feedback: Experimental |
Behavioral: Data analysis and Feedback
Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Exclusion Criteria:
Contact: Karl H. Scholz, MD. | +49-5121-90-5035 | prof.dr.k.scholz@bernward-khs.de |
Contact: Dorothe Ahlersmann, MD. | +49-5121-90-1036 | doro.ahlersmann@web.de |
Germany, Niedersachsen | |
St.Bernward Hospital | Recruiting |
Hildesheim, Niedersachsen, Germany, 31134 | |
Contact: Karl H Scholz, MD. +49-5121-90-5035 prof.dr.k.scholz@bernward-khs.de | |
Contact: Dorothe Ahlersmann, MD. +49-5121-90-1036 doro.ahlersmann@web.de | |
Principal Investigator: Karl H. Scholz, MD. |
Study Director: | Karl H. Scholz, MD. | St.Bernward Hospital |
Responsible Party: | St.Bernward Hospital Hildesheim ( Karl Heinrich Scholz, MD ) |
Study ID Numbers: | GOE-01-10-07 |
Study First Received: | November 18, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00794001 |
Health Authority: | Germany: Federal Ministry of Education and Research |
myocardial infarction angioplasty data feedback continuous quality improvement |
STEMI Feedback Quality Assurance, Health Care |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |