跳至主要内容
临床试验/NCT00794001
NCT00794001招募中不适用

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.

Karl Heinrich Scholz2 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2007年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50,000
试验地点
2
主要终点
Contact to Balloon Time

研究概览

简要总结

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).

详细描述

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.

The multi-phase FITT-STEMI project is structured as follows:

Part I (Pilot Phase)

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.

Part II (Implementation Phase)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • STEMI-patients with duration of infarct-related symptoms longer than 24 hours are excluded

结局指标

主要结局

Contact to Balloon Time

时间窗: six consecutive three month periods (quarters)

次要结局

  • mortality (in-hospital-mortality; 30-day-mortality; 1-year-mortality)(six consecutive three month periods (quarters))

研究者

发起方
Karl Heinrich Scholz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karl Heinrich Scholz

Professor Dr.

St.Bernward Hospital

研究点 (2)

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