跳至主要内容
临床试验/NCT01609465
NCT01609465Unknown不适用

Prognostic Models for People With Stable Coronary Artery Disease

University College, London1 个研究点 分布在 1 个国家目标入组 300,000 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300,000
试验地点
1

研究概览

简要总结

There is currently no published algorithm for secondary prevention prognosis of CHD that is representative of the England GP-registered population and that includes both symptomatic and asymptomatic patients (as identified through primary care). In this paper the investigators will exploit routinely collected information in clinical practice to model CHD prognosis based on a large contemporary open cohort of stable CAD patients. Although the investigators model is based on data from GP practices in England only, the investigators believe that this population is sufficiently heterogeneous in terms of ethnic mix, socioeconomic background, predisposing characteristics and lifestyles to generate a prognostic model with good generalizing power to the wider population.

Among the research questions the investigators will try to answer is whether established risk factors for primary care prevention (smoking, hypertension, dyslipidaemia, diabetes) are also reliable for risk-stratification of patients who have already developed CAD. Similarly, the investigators will examine whether strong predictors of adverse outcomes in ACS patients in the short term, such as admission SBP and heart rate, are also associated with their long term prognosis.

详细描述

Objectives

  1. To use routinely collected primary care and clinical audit (MINAP) data for patients in England to develop and validate prognostic models for people with stable CAD.
  2. To identify key prognostic factors for progression to MI or fatal CHD and compare their strength among clinically important subgroups.
  3. To estimate the risk distribution to specific time horizons overall and within clinically important subgroups.
  4. To use estimates derived from the model to inform subsequent decision models relating to e.g. selection of patients for CABG or second-line anti-platelet agents (e.g. clopidogrel).

The outcome of primary interest is fatal CHD & non-fatal MI. As a secondary outcome we will model all cause mortality. Incidence for these endpoints will be estimated over a period of up to 5 years depending on the quality and availability of follow-up in the cohort. We may cautiously extend to other endpoints, including CVD and endpoints that reflect symptomatic status (e.g. nitrate use).

We plan to follow the reporting guidelines set out in the forthcoming work led by Atman and Moons.

Data and methods

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

入选标准

  • Eligible general practices were defined as practices that meet standards for acceptable levels of data recording (i.e. audits demonstrated that "at least 95% of relevant patient encounters are recorded and data meet quality standards for epidemiological research"7), and have consented to linkage with HES and MINAP (approximately 200 practices).

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harry Hemingway

Professor of Clinical Epidemiology

University College, London

研究点 (1)

Loading locations...

相似试验