Micro-nanoplastic Exposure and Coronary Microcirculatory Dysfunction as Well as Cardiovascular Outcomes
Association of Micro-Nanoplastic Exposure With Coronary Microvascular Dysfunction and Subsequent Cardiovascular Outcomes: A Prospective Cohort Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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.
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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.
Using a catheter to perform invasive coronary functional assessment, including flow fraction reserve(FFR), coronary flow reserve (CFR) and index of microcirculation resistance (IMR)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Baseline Peripheral Circulatory MNPs Concentration(μg/g, particles/ml)
Periodo de tiempo: baseline
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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
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baseline
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Coronary Microvascular Function
Periodo de tiempo: baseline
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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.
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baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Baseline Intracoronary MNPs Concentration(μg/g, particles/ml)
Periodo de tiempo: Baseline
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Using multi-modal omics methodologies (Py-GC/MS, LDIR, and SEM-EDS), the investigators will evaluate the correlation between the total baseline intracoronary 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 both peripheral circulating blood and coronary sinus blood, and baseline coronary microvascular function.
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Baseline
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2 years Follow-up MACE
Periodo de tiempo: 2 years
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Major Adverse Cardiovascular Events (MACE) is defined as a composition endpoint including all-cause death, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to unstable angina, or heart failure events
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2 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Baseline Peripheral MNPs Subpopulations
Periodo de tiempo: Baseline
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Using multi-modal omics methodologies (Py-GC/MS, LDIR, SEM-EDS), the investigators will evaluate the correlations between CMD and multiple variables of MNPs in both peripheral circulating blood and coronary sinus blood, including MNP particle counts, morphological characteristics of each specific particle type (particle size, shape, polymer type, surface charge, etc.)
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Baseline
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Baseline Intracoronary MNPs Subpopulations
Periodo de tiempo: Baseline
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Using multi-modal omics methodologies (Py-GC/MS, LDIR, SEM-EDS), the investigators will evaluate the correlations between CMD and multiple variables of MNPs in both peripheral circulating blood and coronary sinus blood, including MNP particle counts, morphological characteristics of each specific particle type (particle size, shape, polymer type, surface charge, etc.)
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Baseline
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Baseline Circulatory Inflammation Biomarkers
Periodo de tiempo: Baseline
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Circulatory Inflammation Biomarkers includes interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), procalcitonin (PCT), among other related molecular indicators.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- MNPs-CMD
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