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

NCT07748767 | Not Yet Recruiting DMC

• 1 other identifier: MNPs-CMD
• Study Type: observational
• Target: 184
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Microvascular Dysfunction (CMD); Microplastic Exposure; Nanoplastics; MACE

Outcome Measures

Primary Outcomes (2)

• 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

  baseline

• 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.

  baseline

Secondary Outcomes (2)

• 2 years Follow-up MACE

  2 years

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

  Baseline

Other Outcomes (3)

• Baseline Peripheral MNPs Subpopulations

  Baseline

• Baseline Intracoronary MNPs Subpopulations

  Baseline

• Baseline Circulatory Inflammation Biomarkers

  Baseline

Study Arms (1)

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.

Other: micro-nanoplastic examination; Procedure: Microvascular Function Examination

Interventions

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.

Micro-nanoplastic Exposure and CVOT

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)

Micro-nanoplastic Exposure and CVOT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 80 years, with clinical indications for planned invasive coronary angiography and coronary functional assessment.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-07