Feedback Intervention and Treatment Times in ST- Elevation Myocardial Infarction
FITT-STEMI
1 other identifier
interventional
50,000
1 country
1
Brief Summary
Part I (Pilot Phase): 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). Part II (Implementation Phase): The Purpose is to prospectively investigate if survival can be improved by stringent use of this concept of formalized data analysis and systematic feedback of procedural and clinical data to all participating physicians and other members of the STEMI patients treating personnel. Part III (Advance Phase): The purpose is to develop, introduce and evaluate prospectively an automated, highly standardized feedback tool informing participating centers on key performance characteristics (procedural and clinical outcomes).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 18, 2008
CompletedFirst Posted
Study publicly available on registry
November 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMarch 30, 2023
March 1, 2023
18.2 years
November 18, 2008
March 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Contact to Balloon Time
six consecutive three month periods (quarters)
Secondary Outcomes (1)
mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality)
six consecutive three month periods (quarters)
Study Arms (1)
Data Feedback
EXPERIMENTALThe intervention is systematic feedback on performance (using predefined quality indicators) to cardiology, ED, and EMS-stakeholders and staff.
Interventions
Data analysis feedback: quarterly meetings with all stakeholders to present data and discuss potential areas of improvement.
Eligibility Criteria
You may qualify if:
- 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- or precordial leads
- new or presumable new left bundle branch block in the presence of typical symptoms
You may not qualify if:
- STEMI-patients with duration of infarct-related symptoms longer than 24 hours are excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karl Heinrich Scholzlead
- ALKK: Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausaerztecollaborator
- The German Heart Foundationcollaborator
- Aerztekammer Niedersachsencollaborator
Study Sites (1)
St.Bernward Hospital
Hildesheim, Lower Saxony, 31134, Germany
Related Publications (12)
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. doi: 10.1161/CIRCULATIONAHA.108.190402. Epub 2008 Aug 13. No abstract available.
PMID: 18703464BACKGROUNDScholz KH, Hilgers R, Ahlersmann D, Duwald H, Nitsche R, von Knobelsdorff G, Volger B, Moller 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. doi: 10.1016/j.amjcard.2007.07.078. Epub 2007 Nov 19.
PMID: 18157964RESULTScholz KH, von Knobelsdorff G, Ahlersmann D, Keating FK, Jung J, Werner GS, Nitsche R, Duwald H, Hilgers R. [Optimizing systems of care for patients with acute myocardial infarction. STEMI networks, telemetry ECG, and standardized quality improvement with systematic data feedback]. Herz. 2008 Mar;33(2):102-9. doi: 10.1007/s00059-008-3120-6. German.
PMID: 18344028RESULTScholz 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.
PMID: 22917457RESULTMaier LS, Maier SK, Scholz KH. Letter by Maier et al regarding article, "Emergency department bypass for ST-segment-elevation myocardial infarction patients identified with a prehospital electrocardiogram: a report from the American Heart Association Mission: Lifeline Program". Circulation. 2014 Mar 4;129(9):e371. doi: 10.1161/CIRCULATIONAHA.113.005631. No abstract available.
PMID: 24589702RESULTScholz KH, Maier SKG, Maier LS, Lengenfelder B, Jacobshagen C, Jung J, Fleischmann C, Werner GS, Olbrich HG, Ott R, Mudra H, Seidl K, Schulze PC, Weiss C, Haimerl J, Friede T, Meyer T. Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial. Eur Heart J. 2018 Apr 1;39(13):1065-1074. doi: 10.1093/eurheartj/ehy004.
PMID: 29452351RESULTScholz KH, Friede T, Meyer T, Jacobshagen C, Lengenfelder B, Jung J, Fleischmann C, Moehlis H, Olbrich HG, Ott R, Elsasser A, Schroder S, Thilo C, Raut W, Franke A, Maier LS, Maier SK. Prognostic significance of emergency department bypass in stable and unstable patients with ST-segment elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2020 Mar;9(1_suppl):34-44. doi: 10.1177/2048872618813907. Epub 2018 Nov 27.
PMID: 30477317RESULTScholz KH, Lengenfelder B, Jacobshagen C, Fleischmann C, Moehlis H, Olbrich HG, Jung J, Maier LS, Maier SK, Bestehorn K, Friede T, Meyer T. Long-term effects of a standardized feedback-driven quality improvement program for timely reperfusion therapy in regional STEMI care networks. Eur Heart J Acute Cardiovasc Care. 2021 May 25;10(4):397-405. doi: 10.1177/2048872620907323. Epub 2020 Jul 29.
PMID: 32723177RESULTScholz KH, Lengenfelder B, Thilo C, Jeron A, Stefanow S, Janssens U, Bauersachs J, Schulze PC, Winter KD, Schroder J, Vom Dahl J, von Beckerath N, Seidl K, Friede T, Meyer T. Impact of COVID-19 outbreak on regional STEMI care in Germany. Clin Res Cardiol. 2020 Dec;109(12):1511-1521. doi: 10.1007/s00392-020-01703-z. Epub 2020 Jul 16.
PMID: 32676681RESULTScholz M, Meyer T, Maier LS, Scholz KH. Infarct-Related Artery as a Donor of Collaterals in ST-Segment-Elevation Myocardial Infarction With Concomitant Chronic Total Occlusion: Challenge of the Double-Jeopardy Thesis. J Am Heart Assoc. 2023 Apr 4;12(7):e028115. doi: 10.1161/JAHA.122.028115. Epub 2023 Mar 21.
PMID: 36942757RESULTScholz P, Friede T, Scholz KH, Grabmaier U, Meyer T, Seidler T. Pre-hospital heparin is not associated with infarct vessel patency and mortality in ST-segment elevation myocardial infarction patients with out-of-hospital cardiac arrest. Clin Res Cardiol. 2024 Aug 1. doi: 10.1007/s00392-024-02499-y. Online ahead of print.
PMID: 39088062DERIVEDScholz KH, Meyer T, Lengenfelder B, Vahlhaus C, Tongers J, Schnupp S, Burckhard R, von Beckerath N, Grusnick HM, Jeron A, Winter KD, Maier SKG, Danner M, Vom Dahl J, Neef S, Stefanow S, Friede T. Patient delay and benefit of timely reperfusion in ST-segment elevation myocardial infarction. Open Heart. 2021 May;8(1):e001650. doi: 10.1136/openhrt-2021-001650.
PMID: 33958491DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karl H. Scholz, MD.
St.Bernward Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor Dr.
Study Record Dates
First Submitted
November 18, 2008
First Posted
November 19, 2008
Study Start
October 1, 2007
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
March 30, 2023
Record last verified: 2023-03