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临床试验/NCT04903041
NCT04903041暂停不适用

A Cardiac Registry to Evaluate and Manage the hsTnI Categorical CVD Risk in Subjects Undergoing Preventive Health Checks (PHC).

Jaime Marino1 个研究点 分布在 1 个国家目标入组 300,000 人开始时间: 2019年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
300,000
试验地点
1
主要终点
Evaluate the hsTnI categorical CVD risk model with the Apollo Healthcare system in subjects attending the Preventive Health Checkups.

研究概览

简要总结

Cardiovascular disease is the leading cause of mortality globally. In India cardiovascular disease leads to death a decade earlier than in western countries. In the past 20 years awareness and classic risk factors and statins have been the main improvements. However, all these factors have not decreased the cardiovascular disease burden. One reason may be because all of the current assessments for cardiac risk are correlants to disease and none are specific to cardiac myocyte status.

详细描述

Development of high-sensitivity assays for cardiac troponin I (hs-TnI) has enhanced the ability to detect low circulating levels of cardiac troponins, which are often present in individuals with common cardiac conditions and risk factors who have not manifested clinical cardiovascular disease (CVD). Lowering the detection threshold of troponin assays has expanded the potential use of cardiac troponins from a diagnostic tool in the setting of acute coronary syndrome to a biomarker for risk stratification in individuals without known CVD. Detectable levels of cardiac troponins have been associated with increased incidence of coronary heart disease (CHD), heart failure (HF), and cardiovascular mortality in community-based studies.

Traditional cardiovascular risk prediction does not identify everyone who will develop cardiovascular disease with up to 50% of individuals having none or only one risk factor at the time of diagnosis. Although traditional risk estimations perform moderately well, there remain significant limitations in their use in the prevention of cardiovascular disease especially at an individual level. At an individual level, the clinician not only needs to correctly identify those at increased risk, but also weigh up the importance of each risk factor and determine who needs medical therapy in addition to lifestyle advice Many risk estimation systems in existence are based on a core set of cardiovascular risk factors and based on participants either selected randomly from the general population or those attending their general practitioner. All these risk scoring systems show a good level of discrimination, for cardiovascular events, with the area under the receiving operator curve ranging from 0.73 to 0.82. However, adopting these risk scoring systems to guide current clinical practice has limitations. First, most of these scoring systems, except QRISK1 and QRISK2 have been developed from old prospective cohorts with participants recruited in the 1980's and 1990's Second, applying risk estimation scores to regions with different rates of baseline rates of cardiovascular disease will lead to either under- or over-estimation of risk: a result of mis-calibration. Third, the value of incorporating new risk factors including biomarkers such as high-sensitivity C reactive protein has been disappointing in improving discrimination, with age and sex alone contributing to 0.70 of the area under the receiver operating curve statistic. None of these risk estimation scores, to date, incorporate a direct measure of cardiac injury such as cardiac troponin and its potential role in guiding primary prevention in a contemporaneous population remains uncertain.

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

  • All men and women above the age of 18 years
  • Lipid profiles ordered
  • HbA1c ordered
  • Creatinine ordered

排除标准

  • 1. Non-consenting subjects

结局指标

主要结局

Evaluate the hsTnI categorical CVD risk model with the Apollo Healthcare system in subjects attending the Preventive Health Checkups.

时间窗: Through study completion, an average of 1 year

Number of individuals classified as high, moderate, low risk based on the pre-defined cut-offs of high-sensitivity troponin I.

次要结局

  • Implementation of recommendation for the low, moderate and high risk in subjects and monitoring the outcome in the cardiac registry database.(Through study completion, an average of 1 year)

研究者

发起方
Jaime Marino
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Jaime Marino

Sr Medical Affairs Manager

Abbott Diagnostics Division

研究点 (1)

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