Association of Micro-Nanoplastic Exposure With Coronary Microvascular Dysfunction and Subsequent Cardiovascular Outcomes: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 184
- 主要终点
- Baseline Peripheral Circulatory MNPs Concentration(μg/g, particles/ml)
研究概览
简要总结
With strict quality control procedures applied throughout microplastic testing, this study will assess the association between baseline circulating micro-nanoplastic exposure and coronary microvascular dysfunction, as well as subsequent long-term cardiovascular outcomes.
详细描述
Using a prospective cohort study design, this study will enroll patients with clinical indications scheduled for invasive coronary angiography and coronary functional assessment. With a two-tiered framework of "pre-intervention baseline exposure assessment + procedural contamination quantification", it will be the first study to systematically evaluate the dose-response relationship between circulating microplastics and nanoplastics (MNPs) levels and coronary microvascular dysfunction (CMD). Through 2 years of follow-up, the effect of MNPs on the long-term prognosis of patients with CMD will also be assessed.
Multi-modal omics technologies including pyrolysis-gas chromatography/mass spectrometry (Py-GC/MS), laser direct infrared spectroscopy (LDIR), and scanning electron microscopy coupled with energy dispersive X-ray spectroscopy (SEM-EDS) will be applied for the qualitative and quantitative detection of MNPs. The index of microcirculatory resistance (IMR) and coronary flow reserve (CFR), measured via the invasive thermodilution method recommended by the European Society of Cardiology (ESC), will be used to define and evaluate CMD.
The core innovations of this protocol are twofold:
The key blood samples for exposure measurement are strictly collected before any medical procedures are performed after admission, to maximally eliminate the confounding bias from iatrogenic interference in baseline MNPs exposure quantification.
A three-level blank quality control system (procedural blank, environmental blank, device blank) is established to realize full-process monitoring and quantification of iatrogenic contamination.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18;
- •Patients with clinical indications for undergoing invasive coronary angiography and coronary functional assessment (including fractional flow reserve [FFR], CFR, and IMR);
- •Voluntarily sign the written informed consent form.
排除标准
- •The surgeon (or attending physician) determines that the patient is not suitable for or cannot tolerate a coronary physiological examination;
- •Intraoperative coronary angiography reveals a stenosis of>90% in any non-left main coronary artery lumen or a stenosis of>50% in the left main coronary artery lumen;
- •Left ventricular ejection fraction <35% or cardiogenic shock or cardiac arrest;
- •Previous history of invasive procedures/treatments;
- •Active inflammatory diseases;
- •Connective tissue disease;
- •History of malignant tumors;
- •Expected lifespan <2 years;
- •Pregnancy or lactation;
- •Subjects who refuse to comply with the pollution control measures set in this study;
- •Currently participating in other interventional clinical trials.
研究组 & 干预措施
Micro-nanoplastic Exposure and CVOT
According to the baseline circulating MNPs exposure level of the patients, participants will be categorized into the high-exposure group and low-exposure group using the median value as the cutoff point.
干预措施: Microvascular Function Examination (Procedure)
Micro-nanoplastic Exposure and CVOT
According to the baseline circulating MNPs exposure level of the patients, participants will be categorized into the high-exposure group and low-exposure group using the median value as the cutoff point.
干预措施: micro-nanoplastic examination (Other)
结局指标
主要结局
Baseline Peripheral Circulatory MNPs Concentration(μg/g, particles/ml)
时间窗: baseline
Using multi-modal omics methodologies (Py-GC/MS, LDIR, and SEM-EDS), the investigators will evaluate the correlation between the total baseline peripheral circulatory concentration of MNPs and the baseline concentration of each specific particle type (reported as mass concentration in μg/g and particle count in particles/mL) in peripheral circulating blood and coronary sinus blood, and baseline coronary microvascular function
Coronary Microvascular Function
时间窗: baseline
Using invasive functional examinations (Coronary Flow Reverse, CFR and Index of Microcirculatory Resistance, IMR) to evaluate coronary microvascular function. Coronary Microvascular Dysfunction (CMD) is diagnosed by CFR\<2.0 and IMR≥25.
次要结局
- Baseline Intracoronary MNPs Concentration(μg/g, particles/ml)(Baseline)
- 2 years Follow-up MACE(2 years)