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
  Purpose

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
Myocardial Infarction
Behavioral: Data analysis and Feedback

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by St.Bernward Hospital:

Primary Outcome Measures:
  • Contact to Balloon Time [ Time Frame: five consecutive three month periods (quarters) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
Experimental: Data Feedback Behavioral: Data analysis and Feedback
Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794001

Contacts
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

Locations
Germany
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.         
Sponsors and Collaborators
St.Bernward Hospital
ALKK: Arbeitsgemeinschaft Kardiologischer Krankenhausaerzte
Investigators
Study Director: Karl H. Scholz, MD. St.Bernward Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karl Heinrich Scholz, MD, St.Bernward Hospital Hildesheim
ClinicalTrials.gov Identifier: NCT00794001     History of Changes
Other Study ID Numbers: GOE-01-10-07
Study First Received: November 18, 2008
Last Updated: November 18, 2008
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by St.Bernward Hospital:
myocardial infarction
angioplasty
data feedback
continuous quality improvement
STEMI
Feedback
Quality Assurance, Health Care

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on October 19, 2014