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Pilot Study on ST Elevation Acute Myocardial Infarction (ARGEN-IAM-ST)

2015年6月2日 更新者:Sociedad Argentina de Cardiología

Relevamiento / Encuesta Nacional de Infarto Agudo de Miocardio Con elevación Del ST

Aim of investigators is to conduct a registry of acute myocardial infarction including a broad network of critical care / coronary care unit throughout Argentina to increase the knowledge about treatments, timing of reperfusion therapy and outcomes, both in-hospital and during short-term follow up.

研究概览

地位

未知

条件

详细说明

Cardiovascular disease is the most common cause of death in the world and in Argentina, as well as a cause of disability and loss of work capacity in adults. Treatment of various forms of serious diseases such as acute ischemic events and heart failure are now supported by scientific studies and allow a markedly reduction in disability and mortality. Access to diagnostic and therapeutic strategies require proper coordination of the health system and far exceed the role of specialists. Given the frequency of these diseases, it is essential to have information on the prevalence and treatment, and the various barriers to access to diagnosis and appropriate treatment. Both for the basic knowledge to evaluate the relevance and effectiveness of corrective action a record of pathologies is required, with information accurate enough to enable the adoption of public policies, and adjusted to national needs.

Scientific societies in cardiovascular field, Argentine Society of Cardiology and Argentine Federation of Cardiology, have a long history of registers and educational programs to improve cardiovascular care. However, these tasks are limited to institutions with academic programs and probably do not reach the majority of our population.

A national survey of high prevalence of cardiovascular diseases, starting with acute myocardial infarction with ST segment elevation, together with the authorities of the National Ministry of Health, would put Argentina at the level of most developed countries in this subject. Knowledge of general and local barriers will allow a rapid implementation of corrective measures and the evaluation of their impact through the permanent record. Improving the quality of cardiovascular patient care, optimizing adherence to standards of diagnosis and treatment can be achieved through different paths as self-knowledge of the institutions of their level of performance and dissemination of coordination measures, generating systematic referral and care networks, diagnostic support systems such as telemedicine, and others that can be assessed globally or regionally according to the identified problems.

Networking will also enable the implementation of initiatives that will result in an increase in the quality of care and generate epidemiological research projects that enhance patient care and outcomes. In conclusion, it will allow to know the problems in depth and adopt measures to improve the quality of care and reduce morbidity and mortality.

The main objective of the survey is to register at national level, in the broadest possible way trying to reach the "universe" of care for this disease in Argentina, aspects of clinical, delays, treatment schedules and results, with sufficient information to quickly allow the adoption of policies to improve the quality of care and subsequent control.

Its fulfilment arises in stages:

  1. Develop a national survey of myocardial infarction with ST segment elevation, aimed at characterization of current evolutions and possible barriers to be improved.
  2. Based on the results, configure an advisory group for public policies in this area to suggest global and regional measures.
  3. Upon completion of the survey, consolidation of a permanent network of cardiovascular disease registry to assess the impact of public policies and their progressive adjustment under the Federal Cardiovascular Disease Registry A national survey of all AMI with ST segment elevation admitted to intensive care areas across the country will take place over a period of 3 consecutive months in each centre.

The inclusion criteria are:

  • Patients admitted with AMI and ST-segment elevation.
  • AMI evolved with new Q waves less than 36 hours evolution.
  • Suspected inferoposterior AMI (horizontal ST depression in V1 to V3, suggestive of acute circumflex coronary artery occlusion).
  • New or presumed new left bundle branch block.

Exclusion criteria:

  • Acute coronary syndrome without ST elevation or non-Q AMI
  • Myocardial infarction of more than 36 hours of evolution. Data on patient characteristics (age, gender, risk factors, history, comorbidities), of the clinical conditions (infarct location, Killip on admission, duration of symptoms), treatments (antiplatelet drugs, reperfusion therapy, adjuvant treatment) and in-hospital (heart failure, post-infarction angina, shock, death) and 30-day evolution will be collected. Emphasis will be placed on the delays for effective treatment. 30 days follow-up will be done by telephone or in person by each centre investigator or through the central coordinating committee.

The data collection will take place in an electronic record specially designed, via web, allowing constant monitoring of the input data. The survey data will be verified or confronted with source documents in at least 30% of the patients included in the survey.

The data analysis will be conducted by a committee of representatives of the organizing researchers of Scientific Societies and the Ministry of Health, presented in relevant scientific meetings and published in the journals of both Societies.

研究类型

观察性的

注册 (预期的)

1500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Carlos D Tajer, MD
  • 电话号码:00 +54 114961-6027
  • 邮箱ctajer@gmail.com

学习地点

    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires、Buenos Aires、阿根廷、1115
        • 招聘中
        • Sociedad Argentina de Cardiología
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with ST elevation Myocardial infarction.

描述

Inclusion Criteria:

  • Patients admitted with AMI and ST-segment elevation.
  • AMI evolved with new Q waves less than 36 hours evolution.
  • Suspected inferoposterior AMI (horizontal ST depression in V1 to V3, suggestive of acute circumflex coronary artery occlusion).
  • New or presumed new left bundle branch block.

Exclusion Criteria:

  • Acute coronary syndrome without ST elevation or non-Q AMI
  • Myocardial infarction of more than 36 hours of evolution.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Appropriate use of reperfusion therapy
大体时间:In-hospital, with an expected average of 5 days.
Timely initiation of reperfusión (door to needle time <30 minutes or door to balloon time <90 minutes).
In-hospital, with an expected average of 5 days.
In-hospital mortality
大体时间:In-hospital, with an expected average of 5 days.
All cause death during initial hospitalization.
In-hospital, with an expected average of 5 days.
All cause mortality
大体时间:30 days.
All cause mortality between symptoms onset and 30 days.
30 days.

次要结果测量

结果测量
措施说明
大体时间
In-hospital complications
大体时间:In-hospital, with an expected average of 5 days.
Heart failure, post-infarction angina, cardiogenic shock or death during initial hospitalization.
In-hospital, with an expected average of 5 days.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Juan Gagliardi, PhD、+54 114961-6027

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年4月1日

初级完成 (预期的)

2015年9月1日

研究完成 (预期的)

2015年10月1日

研究注册日期

首次提交

2015年5月26日

首先提交符合 QC 标准的

2015年5月29日

首次发布 (估计)

2015年6月1日

研究记录更新

最后更新发布 (估计)

2015年6月3日

上次提交的符合 QC 标准的更新

2015年6月2日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 001 (NavyGHB)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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