跳至主要内容
临床试验/CTRI/2017/10/010137
CTRI/2017/10/010137进行中(未招募)不适用

A registry of Primary Precutaneous Coronary Interventions for Acute Elevation ST Elevation Myocardial Infarction in Kerala

Cardiological Society of India Kerala Chapter35 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2015年3月30日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
4,000
试验地点
35
主要终点
All-cause mortality (1 year)

研究概览

简要总结

The Southern Indian state of Kerala has served as a model health delivery system for the rest of India, with the highest life expectancy rates among the Indian states. While cardiovascular diseases are the leading cause of mortality in India, the proportion of population dying from cardiovascular diseases is even higher in Kerala, with cardiovascular mortality rates exceeding those of industrialized nations. Population level interventions to effect primary prevention of cardiovascular diseases are imminently required to achieve sustainable reduction in the burden of cardiovascular diseases. There is a high prevalence of conventional cardiovascular risk factors including diabetes, hypertension, dyslipidemia and central obesity in Kerala. When seen in the context of a projected increase in the prevalence of diabetes in India over the next few decades, an alarming increase in the incidence of cardiovascular diseases can be expected. Acute coronary syndromes especially ST elevation myocardial infarction (STEMI) continues to be among one of the leading cause of cardiovascular mortality in Kerala. In order to reduce mortality and improve long-term outcomes following STEMI it is essential to develop systems of care to facilitate rapid reperfusion in these patients, using appropriate pharmacologic and interventional therapies. Over the past five years the state of Kerala has witnessed a rapid expansion in the number of percutaneous coronary intervention (PCI)-capable hospitals which can be designated as receiving centres for STEMI patients. With 71 cardiac catheterization laboratories in the state of Kerala, there is one cardiac catheterization laboratory available per 470,000 population, thereby substantially increasing the numbers of patients who potentially have timely access to cardiac catheterization services. The rates of primary PCI for STEMI have shown only marginalimprovement from 8.0% in the CREATE registry to 12.9% in the Kerala ACS registry (2007-2009). However, contemporary anecdotal evidence points out to more than 80% primary PCI rates for STEMI, at many PCI-capable centres in Kerala. We believe that the rapid expansion of cardiac catheterization services in Kerala offers a unique opportunity to assess the impact of this health infrastructure expansion on STEMI mortality and outcomes.

One of the objectives of the PARK is to ascertain if patients presenting to PCI-capable hospitals in Kerala have a significant improvement in mortality and major adverse cardiovascular events, compared to patients enrolled in the Kerala ACS registry and CREATE registry. The PARK findings will help in analysing how the STEMI cardiac catheterization services and adjunctive pharmacotherapy fare in comparison to current standards (ACC/AHA guidelines).

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.All patients more than 18 years presenting with acute ST elevation Myocardial Infarction with symptom duration less than 24 hours, undergoing primary percutaneous coronary interventions (PCI).
  • Diagnostic ST elevation in the absence of LVH or LBBB as defined by ESC/ACC/AHA/World Heart federation task force for the universal definition of Myocardial infarction as new ST elevation at the J point in at least two contiguous leads of more than 2mm in men or > 1.5 mm in women in leads V2-V3 and /or more than or equal to 1 mm in other contiguous chest leads or limb leads.
  • At least one cardiac biomarker elevation above the 99th percentile upper reference limit required.
  • 2.New onset or presumed new onset LBBB in the approprite context of ischemic chest pain will also be considered as STEMI equivalent.

排除标准

  • 1.Presentation after 24 hours of onset of chest pain 2.Inability to provide informed consent 3.Patients with STEMI who were thrombolyzed at referring hospitals 4.Patients developing STEMI in-hospital following PCI.

结局指标

主要结局

All-cause mortality (1 year)

时间窗: 30/03/2018

Composite of all-cause mortality/ non-fatal MI/ TVR/stroke at one year

时间窗: 30/03/2018

In-hospital Mortality

时间窗: 30/03/2018

次要结局

  • Cardio vascular Death/Nonfatal MI,/Stroke/Unplanned hopitalisation for ACS or HF at one month(Non-fatal MI at one year)

研究者

申办方类型
Other [Doctors organiation]

研究点 (35)

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