Micro-nanoplastic Exposure and Coronary Microcirculatory Dysfunction as Well as Cardiovascular Outcomes

Официальное название

Association of Micro-Nanoplastic Exposure With Coronary Microvascular Dysfunction and Subsequent Cardiovascular Outcomes: A Prospective Cohort Study

Обзор

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.

Подробное описание

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.

The entire study design strictly adheres to current technical recommendations and industry consensus in clinical practice, and demonstrates high feasibility, reproducibility, and reliability.

Вмешательства

• Другое micro-nanoplastic examination
  In this prospective cohort study, the investigators plan to perform a low-contamination protocol for the detection of circulating micro-nanoplastic particles in eligible subjects prior to the administration of invasive coronary angiography and concomitant coronary microvascular function assessment, so as to clarify the impact of micro-nanoplastic exposure status on coronary microvascular function and long-term prognosis.
• Процедура Microvascular Function Examination
  Using a catheter to perform invasive coronary microcirculation functional assessment, including coronary flow reserve (CFR) and index of microcirculation resistance (IMR)

Первичные конечные точки

• Baseline Peripheral Circulatory MNPs Concentration(μg/g, particles/ml) [Срок оценки: baseline]
• Coronary Microvascular Function [Срок оценки: baseline]

Вторичные конечные точки (2)

• 2 years Follow-up MACE [Срок оценки: 2 years]
• Baseline Intracoronary MNPs Concentration(μg/g, particles/ml) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Subjects with clinical indications for invasive coronary angiography and coronary functional assessment;
• Voluntarily sign the written informed consent form.

Критерии исключения

• History of previous myocardial infarction;
• History of prior PCI or coronary artery bypass grafting (CABG);
• Intraoperative coronary angiography shows non-left main coronary artery diameter stenosis >90%, or left main coronary artery diameter stenosis >50%;
• Left ventricular ejection fraction < 35%;
• Severe valvular heart disease with planned or prior valve replacement, confirmed cardiomyopathy, or constrictive pericarditis;
• Active inflammatory disease;
• Active malignant tumor or life expectancy < 1 year;
• Pregnant or lactating women;
• Subjects who refuse to comply with the pollution control measures set in this study;
• Currently participating in other interventional clinical trials.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07748767 · MNPs-CMD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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