临床试验/CTRI/2025/08/092597

CTRI/2025/08/092597尚未招募不适用

Cardiovascular Acute event risk from PolluTion exposURE in ACS patients (CAPTURE-ACS study): A Prospective, Quasi-Experimental Observational Study

Subharti Medical College1 个研究点分布在 1 个国家目标入组 320 人开始时间: 2025年8月30日最近更新: 2025年8月6日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 320
试验地点: 1
主要终点: To quantify the association between short term ambient pollutant exposure 1, 7 and 15 days prior to admission, long term exposure more than 12 months prior to the index event and ACS incidence in a high pollution, urban Indian cohort

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will delineate the acute effects of ambient air pollution on ACS incidence, severity, biomarkers, and short-term outcomes in India’s high-risk urban populations. It could shape region-specific cardiovascular prevention strategies, inform risk prediction models, and guide public health policies on air quality management.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

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

入选标准

•Adults 18 years or more with ACS confirmed per Fourth Universal Definition of ACS.

排除标准

•Type 2 MI (per ESC 2023 guidelines) • Takotsubo cardiomyopathy • Chronic inflammatory or autoimmune diseases.

结局指标

主要结局

To quantify the association between short term ambient pollutant exposure 1, 7 and 15 days prior to admission, long term exposure more than 12 months prior to the index event and ACS incidence in a high pollution, urban Indian cohort

时间窗: To quantify the association between short term ambient pollutant exposure 1, 7 and 15 days prior to admission, long term exposure more than 12 months prior to the index event and ACS incidence in a high pollution, urban Indian cohort

次要结局

To stratify ACS severity (Killip class, STEMI vs NSTEMI prevalence) across Air Quality Index categories(Baseline, 1 week, 15 days, 30 days, 1 year)
To model dose-response relationships between PM exposure lag 0–2 days & exposure to other pollutants & inflammatory biomarkers hs-CRP, IL-6 using Generalized Additive Models(Baseline, 1 week, 15 days, 30 days, 1 year)
To assess whether PM exposure thresholds (25th vs. 75th percentile) predict in-hospital mortality & Left Ventricular Ejection Fraction reduction(Baseline, 1 week, 15 days, 30 days, 1 year)
To evaluate the association of co-morbdities & confounders like smoking, diabetes, hypertension & dyslipidemia on effect of air pollution on ACS(Baseline)
To assess TIMI thrombus grade variation with prior 3-day PM averages(3 days)
To analyze short-term (30-day) MACE rates across AQI quartiles(30 days)
To compare IL-6 & hs-CRP levels & other biomarkers in ACS patients admitted during ‘severe pollution’ vs. ‘good air quality’ days(Baseline, 1 week, 15 days, 30 days, 1 year)
To evaluate the association between NO exposure & arrhythmia occurrence during hospitalization(Baseline, 1 week, 15 days, 30 days, 1 year)
To determine pollutant-specific risk contribution to ACS subtypes(Baseline, 1 week, 15 days, 30 days, 1 year)
To explore geospatial exposure gradients using inverse distance weighted pollution estimates & their association with ACS outcomes(Baseline, 1 week, 15 days, 30 days, 1 year)
To explore role of seasonal & temporal variations & their association with ACS incidence & outcomes(Baseline, 1 week, 15 days, 30 days, 1 year)
To validate the feasibility of integrating environmental exposure data into ACS risk stratification models in Indian tertiary centers The Mehta-Sethi Score(Baseline, 1 week, 15 days, 30 days, 1 year)

研究者

发起方

Subharti Medical College

申办方类型

Private medical college

责任方

Principal Investigator

主要研究者

Yashendra Sethi

Subharti Medical College

研究点 (1)

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