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NCT Number: NCT07748767

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

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.

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Key information

Conditions

Coronary Microvascular Dysfunction (CMD) MACE Microplastic Exposure Nanoplastics

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

micro-nanoplastic examination

Other

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.

Microvascular Function Examination

Procedure

Using a catheter to perform invasive coronary microcirculation functional assessment, including coronary flow reserve (CFR) and index of microcirculation resistance (IMR)

Primary outcomes

  1. Baseline Peripheral Circulatory MNPs Concentration(μg/g, particles/ml)

    Time frame: 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

  2. Coronary Microvascular Function

    Time frame: 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.

Secondary outcomes

  1. 2 years Follow-up MACE

    Time frame: 2 years

    Major Adverse Cardiovascular Events (MACE) is defined as a composition endpoint including all-cause death, non-fatal myocardial infarction, unexpected revascularization and re-hospitalized due to heart failure.

  2. Baseline Intracoronary MNPs Concentration(μg/g, particles/ml)

    Time frame: Baseline

    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.

Other outcomes

  1. Baseline Peripheral MNPs Subpopulations

    Time frame: Baseline

    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.)

  2. Baseline Intracoronary MNPs Subpopulations

    Time frame: Baseline

    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.)

  3. Baseline Circulatory Inflammation Biomarkers

    Time frame: Baseline

    Circulatory Inflammation Biomarkers includes interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP), procalcitonin (PCT), among other related molecular indicators.

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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