Incidence of Coronary Artery Disease Worsening Events in Patients Exposed to Indoor and Ambient Air Pollution: A Prospective Cohort Study from two Districts of Punjab.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Temporal changes in biochemical, physiological and clinical parameters over the study period.
研究概览
简要总结
Background: The burden of coronary artery disease, morbidity and mortality around the world is rapidly escalating and the burden is equivalently high in India. Recent research suggest that increasing air pollution is a significant factor for CAD. Due to agrarian backdrop, the rural environment is also impacted by anthropogenic, chemicals such as current use of pesticide and persistent organic pollutants. Literature review suggest a strong association between short and long-term ambient air pollution exposure and all cause cardiovascular mobility and mortality. However, the existing literature is primary restricted to depicting the association between exposure to selective air pollutants and incidence of CAD is over longer duration which is very resource intensive and non-feasible to replicate in absence of existing hot and historical environmental surveillance data. Patch evidence show that air pollution also exacerbate existing CAD, but this has not been reported in Indian population. that the aim will be to study the role of ambient and indoor pollution in two districts of Punjab towards worsening of clinical status among adults who have been recently diagnosed with coronary artery disease.
Methods: we will adopt a prospective study design over 18 months among eight locations of two districts of Punjab that differ from each other in terms of air, quality, population, size, industrialisation and traffic movements. We will include adults any is equal to 110 in each district with a known history of PAD in last year. We will collect patients health data at baseline and subsequently at the end of each partsix monthly. We will collect ambient air pollution data from each side every month and indoor air pollution data from each participant house for one month in each quarter. The primary dependent variable would be to would be the event that suggest worsening of CAD during the study period. It would be assessed during the history of chest pain, progression of heart failure, arrangement of biochemical, botanical profile, or a need for increased medica consultations or hospitalisation.
Expected outcomes, environmental data will be used to estimate the Hazard question, cumulative exposure and average annual exposure to develop linear or non-linear statistical models that explore the relationship between disease worsening due to exposure. Further the Cox proportional Hazard method will be deployed to observe in independent variables impact on patients outcome, which will also be graphically depicted using the Kaplan near survival curve. Metanalysis will be deployed to show the estimates from the two sides.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 55.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Residing in the study area for at least one year before the onset of the index cardiac event.
- •A history of CAD diagnosis confirmed by physician or admission to hospital due to Chest pain (angina), Shortness of breath, Fatigue, or Heart attack, or currently on medical management.
排除标准
- 未提供
结局指标
主要结局
Temporal changes in biochemical, physiological and clinical parameters over the study period.
时间窗: The data will be collected at baseline, and then subsequently at the end of 6, 12, 18 and 24 months.
Changes attributed to exposure relative to the non-exposed group.
时间窗: The data will be collected at baseline, and then subsequently at the end of 6, 12, 18 and 24 months.
Association between environmental exposure and clinical outcomes over the study period.
时间窗: The data will be collected at baseline, and then subsequently at the end of 6, 12, 18 and 24 months.
次要结局
未报告次要终点
研究者
Dr Madhur Verma
All India Institute of Medical Sciences, Bathinda
