跳至主要内容
临床试验/NCT04412655
NCT04412655Unknown不适用

International Study on Acute Coronary Syndromes - ST-segment Elevation Myocardial Infarction COVID 19

Università degli Studi del Piemonte Orientale "Amedeo Avogadro"1 个研究点 分布在 1 个国家目标入组 6,609 人开始时间: 2020年5月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
6,609
试验地点
1
主要终点
Number of patients undergoing primary angioplasty

研究概览

简要总结

The ISACS STEMI COVID-19 has been established in response to the emerging outbreak of COVID-19 to provide a European overview to estimate the real impact of COVID-19 pandemic on treatment and outcome of STEMI by primary angioplasty, and to identify any potential category of patients at risk for delay to treatment or no presentation.

详细描述

This is a retrospective multicenter registry including at least 40 European primary PCI centers with > 120 primary PCI/year (with expected average > 10/month), with the case load of STEMI not expected to be affected by a potential planned reorganization of the STEMI network. The inclusion period will be of 2 months (from March 1st until April 30th). The data will be compared with those retrospectively collected in the same time window of 2019.

Inclusion criteria: STEMI treated by primary angioplasty. Primary study outcome: Number of STEMI patients undergoing primary angioplasty. Secondary study outcomes: Ischemia time and the number of late presenters (> 12 hours from symptoms onset); 3) Door-to-balloon time and the number of patients with a DTB > 30 minutes); 4) In-Hospital mortality.

Data Collection: Data will be collected anonymized through a dedicated CRF. Each center will identify a local Principal Investigator. We will collect information on the study center, demographic, clinical, procedural data. Furthermore, we will collect data on total ischemia time, door-to-balloon time, type of access to the emergency system, COVID positivity, PCI procedure, data on in-hospital mortality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • STEMI Patients undergoing mechanical reperfusion

排除标准

  • 未提供

结局指标

主要结局

Number of patients undergoing primary angioplasty

时间窗: March April 2019 and 2020

Number of patients undergoing primary angioplasty

Number of patients undergoing primary angioplasty later than 12 hours from symptoms onset;

时间窗: March April 2019 and 2020

Number of patients undergoing primary angioplasty later 12 hours from symptoms onset;

In-hospital mortality

时间窗: March April 2019 and 2020

In-Hospital mortality

Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission

时间窗: March April 2019 and 2020

Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission

次要结局

未报告次要终点

研究者

发起方
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验