Coronary Microvascular Dysfunction (CMD)NCT07748767
Micro-nanoplastic Exposure and Coronary Microcirculatory Dysfunction as Well as Cardiovascular Outcomes
An observational study of Coronary Microvascular Dysfunction (CMD) and Microplastic Exposure, run by Beijing Anzhen Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Microvascular Dysfunction (CMD), Microplastic Exposure, Nanoplastics
- What is being tested?
- micro-nanoplastic examination and Microvascular Function Examination
- Type of treatment
- Surgery or procedure
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years old, with clinical indications for planned invasive coronary angiography and coronary functional assessment.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: Association of Micro-Nanoplastic Exposure With Coronary Microvascular Dysfunction and Subsequent Cardiovascular Outcomes: A Prospective Cohort Study
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.
Read the detailed description
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.
- Being tested
- micro-nanoplastic examination, Microvascular Function Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-nanoplastic examinationOther
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 ExaminationProcedure or 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: micro-nanoplastic examination; Procedure: Microvascular Function Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: baseline
Secondary outcomes (2)
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
Measured: 2 years
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular Dysfunction (CMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748767
- Sponsor's protocol ID
- MNPs-CMD
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Micro-Nanoplastic Exposure With Coronary Microvascular Dysfunction and Subsequent Cardiovascular Outcomes: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07748767
- Acronym / sponsor ID
- MNPs-CMD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro-nanoplastic Exposure and CVOT | – | Other: micro-nanoplastic examination, Procedure: Microvascular Function ExaminationAccording 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years old, with clinical indications for planned invasive coronary angiography and coronary functional assessment.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micro-nanoplastic examinationIn 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. | Other | Micro-nanoplastic Exposure and CVOT |
| Microvascular Function ExaminationUsing a catheter to perform invasive coronary functional assessment, including flow fraction reserve(FFR), coronary flow reserve (CFR) and index of microcirculation resistance (IMR) | Procedure or surgery | Micro-nanoplastic Exposure and CVOT |
Primary outcome
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
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.
2 secondary outcomes
2 years Follow-up MACE
Time frame: 2 years
Baseline Intracoronary MNPs Concentration(μg/g, particles/ml)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Microvascular Dysfunction (CMD) and Microplastic Exposure, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Peripheral Circulatory MNPs Concentration(μg/g, particles/ml) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.