NCT04255537Unknown不适用
Clinical Governance of Patients With Acute Coronary Syndrome in Italy
Fondazione IRCCS Policlinico San Matteo di Pavia9 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2018年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 9
- 主要终点
- Time to reperfusion in patients with STEACS and optimal medical therapy at hospital discharge in patients with a final diagnosis of MI or UA.
研究概览
简要总结
This is a prospective, observational, multicenter study that enroll consecutive and all-comers patients hospitalized with a diagnosis of Acute Coronary Syndrome (ACS) at admission.
详细描述
This is a Quality Improvement Program which enroll all the consecutive patients hospitalized with ACS. The data elements that are central to the study include the primary and secondary quality indicators (QIs) that are used to define the performance and to promote improved quality of care.
At least 3000 patients will be enrolled. The primary endpoint are assessed in-hospital, at admission and discharge. Patients will be followed for 1 year after the ACS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEACS patients: symptoms of myocardial ischemia and persistent (i.e. > 20 min) ST elevation in at least two contiguous ECG leads. N.B. Positive biomarkers of cardiac necrosis (i.e. troponin) are not required to confirm the diagnosis. New or presumably new left-bundle branch block at presentation occurs infrequently, may interfere with ST-elevation analysis, and should not be considered diagnostic of acute myocardial infarction (MI) in isolation.
- •NSTE-ACS patients: symptoms of myocardial ischemia of at least 10 minutes without persistent ST elevation in at least two contiguous ECG leads. To be included in this category patients should have at least one of the following two conditions: a) ECG evidence of NSTEACS defined as T wave inversion in leads with dominant R waves of at least of at least 1 mm (100 μV) or ST segment depression of at least 0.5 mm (50 μV) and/or b) Biomarker evidence of NSTEACS defined as at least one positive (i.e. above the 99th percentile upper reference limit) troponin value (i.e. NSTEMI)
- •A written informed consent (to agree for a contact, usually by telephone) is required only to patients who are discharged alive.
排除标准
- •Subjects who, in the opinion of the investigator, are unable to comply with study follow up procedures, including, but not limited to, patients who are in prison, who are expected to move to a remote country, or who refuse to be followed should be excluded.
结局指标
主要结局
Time to reperfusion in patients with STEACS and optimal medical therapy at hospital discharge in patients with a final diagnosis of MI or UA.
时间窗: Baseline
次要结局
- To monitor the characteristics, treatments, and outcomes of patients hospitalized with ACS.(Baseline)
- To measure adherence to a wide range of QIs within multiple domains of care including optimal ACS diagnosis, therapy, and individualized risk assessment through monitoring of process of care measures and benchmarked quality-of-care feedback reports.(Baseline)
- Examine associations of program participation with trends of QIs adherence over 1 year.(1 year.)
- Identify barriers to implementing guideline recommendations for patients with AMI, and develop effective strategies to overcome these barriers(Baseline)
- To explore the association between evidence-based acute treatment strategies and risk-adjusted clinical outcomes.(1 year.)
- To assess utilization of diagnostic imaging, laboratory tests and invasive procedures; and track hospital/coronary care unit length-of-stay data.(Baseline)
- Assess trends in medication dosing patterns, and improve drug safety through targeted quality feedback related to medication overdosing.(Baseline)
研究者
Sergio Leonardi
MD
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (9)
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