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临床试验/NCT01760382
NCT01760382
Unknown
不适用

REgister of Myocardial Infarction Patients Treated by the NOVAra STE-MI Network

Azienda Ospedaliero Universitaria Maggiore della Carita1 个研究点 分布在 1 个国家目标入组 700 人2011年1月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Acute Myocardial Infarction
发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
入组人数
700
试验地点
1
主要终点
Successful reperfusion
最后更新
11年前

概览

简要总结

Myocardial infarction (MI) outcomes strictly depend on the time to reponed the infarct-related coronary artery. Networks have been activated in the last years in many countries to achieve fast track access of patients with ST-elevation MI to hospital with h24 primary PCI availability or directly to Cath Labs. From 2011 a regional STEMI network have been formally activated in Piedmont. The aim of our registry is to monitor the activity of the STEMI network in the large suburban area of Novara (population of about 800.000 subjects).

详细描述

Myocardial infarction (MI) outcomes strictly depend on the time to reponed the infarct-related coronary artery. Networks have been activated in the last years in many countries to achieve fast track access of patients with ST-elevation MI to hospital with h24 primary PCI availability or directly to Cath Labs. From 2011 a regional STEMI network have been formally activated in Piedmont. The aim of our registry is to monitor the activity of the STEMI network in the large suburban area of Novara (population of about 800.000 subjects). Novara STEMI network depends on the 118 service (the same of 911 in USA). When a call for suspected MI is processed, an Ambulance capable of transmitting a 12D ECG to the Hub Center is sent to the patient domicile. If the ECG and history suggest STEMI and transport time \<90min, the patient is given aspirin and sent to Hub Hospital for primary PCI. If transport time is estimated \>90min thrombolysis with TNK is performed in ambulance and the patient is sent to Hub Hospital for rescue PCI or re-evaluation in case of reperfusion. Inclusion criteria: all patients with STEMI admitted to Novara Hospital (3rd level Hub with Cardiac Surgery Facility). No exclusion criteria. Patients will be divided for comparisons in 2 groups (Group A: people admitted to hospital through the STEMI network. Group B: people admitted for STEMI through the Emergency department of the Novara Hospital or via secondary trasports regulated by Spoke Hospitals). Quality factors: recording of time from symptoms onset and 1st medical contact, time from 1st medical contact and coronary angiography (door to needle time) and time from 1st medical contact and mechanical reperfusion (door to balloon time), angiographic indexes of reperfusion (baseline and postprocedural TIMI flow, blush grade, corrected TIMI frame count), trends for ST elevation resolution,trends for troponin and CK-MB dismission, baseline and postprocedural echocardiography. Clinical outcomes will be successful reperfusion, in-hospital cardiac mortality, in-hospital reinfarction and in-hospital stent thrombosis. Moreover patients will be followed up clinically for at least 1 year (outcomes: cardiac mortality, reinfarction, symptoms/ischemia driven target vessel revascularization).

注册库
clinicaltrials.gov
开始日期
2011年1月
结束日期
2016年3月
最后更新
11年前
研究类型
Observational
性别
All

研究者

发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
责任方
Principal Investigator
主要研究者

Lupi Alessandro

Principal investigator

Azienda Ospedaliero Universitaria Maggiore della Carita

入排标准

入选标准

  • chest pain or equivalents (dyspnea, epigastrial pain) within 12 hours from onset (also after 12 hours if patient still symptomatic)
  • ST segmnent elevation on more 2 or more contiguous ECG leads
  • reperfusion treatment by primary PCI

排除标准

  • symptoms beginning more than 12 hours before (with patient asymptomatic)
  • survival estimated \< 6 months according to the treating physician

结局指标

主要结局

Successful reperfusion

时间窗: 1 day

Successful reperfusion of the infarct related artery according to both clinical (\>70% reduction of ST elevation 90min after primary PCI, in comparison to baseline) and angiographic criteria (restoration of TIMI 3 flow with blush grade at least 2).

次要结局

  • In Hospital Cardiac Mortality(1 week)
  • In hospital myocardial infarction(1 week)
  • In hospital stent thrombosis(1 week)

研究点 (1)

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