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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by St.Bernward Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ALKK: Arbeitsgemeinschaft Kardiologischer Krankenhausaerzte
Information provided by:
St.Bernward Hospital
ClinicalTrials.gov Identifier:
NCT00794001
First received: November 18, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 18, 2008
November 18, 2008
October 2007
December 2011   (final data collection date for primary outcome measure)
Contact to Balloon Time [ Time Frame: five consecutive three month periods (quarters) ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Myocardial Infarction
Behavioral: Data analysis and Feedback
Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.
Experimental: Data Feedback
Intervention: Behavioral: Data analysis and Feedback

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
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
 
NCT00794001
GOE-01-10-07
No
Karl Heinrich Scholz, MD, St.Bernward Hospital Hildesheim
St.Bernward Hospital
ALKK: Arbeitsgemeinschaft Kardiologischer Krankenhausaerzte
Study Director: Karl H. Scholz, MD. St.Bernward Hospital
St.Bernward Hospital
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP