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

ConditionsCoronary Microvascular Dysfunction (CMD)Microplastic ExposureNanoplasticsMACE
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients older than 18 years old, with clinical indications for planned invasive coronary angiography and coronary functional assessment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • micro-nanoplastic examination

    Other intervention

    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/Surgery

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

Treatment groups

184 Participants
are divided into 1 treatment group
Group A: Micro-nanoplastic Exposure and CVOT2 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
baseline
2

Coronary Microvascular Function

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.

Time frame
baseline

Secondary outcomes

1

2 years Follow-up MACE

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

Time frame
2 years
2

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

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.

Time frame
Baseline

Other outcomes

1

Baseline Peripheral MNPs Subpopulations

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.)

Time frame
Baseline
2

Baseline Intracoronary MNPs Subpopulations

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.)

Time frame
Baseline
3

Baseline Circulatory Inflammation Biomarkers

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

Time frame
Baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: