The Correlation Between Obstructive Sleep Apnea-Related Nocturnal Hypoxemia Parameters and Coronary Microvascular Dysfunction: A Prospective Cohort Study (SLEEP-CMD)

NCT07315399 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Anzhen Hospital

Phase

Observational

Started

2025-12-30

Last updated

2026-01-02

Condition(s) studied

OSA - Obstructive Sleep ApneaCoronary Microvascular Dysfunction (CMD)Coronary Artery Disease (CAD)

Investigational drug(s) / intervention(s)

Polysomnography

Polysomnography: 1. Polysomnography (PSG) All patients underwent overnight polysomnography using a diagnostic system during their hospitalization. The following nocturnal respiratory parameters were recorded: Apnea-Hypopnea Index (AHI), heart rate-related parameters (MaxHR, MHR, MinHR), Oxygen Desaturation Index (ODI), mean apnea duration, longest apnea duration, mean hypopnea duration, longest hypopnea duration, minimum oxygen saturation (minSpO2), and the percentage of time with oxygen saturation below 90% (T90). 2. Angio-IMR Assessment Data Acquisition and Technique: Clear angiographic images of the LAD, LCX, and RCA were acquired from at least two different projection angles. Images were required to be free of vessel overlap and foreshortening. Three-dimensional reconstruction and hemodynamic calculations were performed using dedicated software (AccuIMR, Version 1.0; ArteryFlow Technology, Hangzhou, Zhejiang, China).An Angio-IMR value \> 25 U was defined as the threshold for diagnosing CMD.

Study summary

In a cohort of patients with suspected myocardial ischemia undergoing sleep studies, the objectives of this study were:

1. To determine the association between various obstructive sleep apnea (OSA)-related nocturnal hypoxemia parameters and coronary microvascular dysfunction (CMD) in patients with suspected myocardial ischemia.
2. To compare the predictive value of nocturnal hypoxemia parameters versus the traditional Apnea-Hypopnea Index (AHI) for coronary microvascular dysfunction.
3. To evaluate the prognostic value of nocturnal hypoxemia parameters in predicting Major Adverse Cardiovascular Events (MACE) during the follow-up period.
4. To explore the potential mediating roles of inflammatory and oxidative stress biomarkers in the relationship between nocturnal hypoxemia parameters and coronary microvascular dysfunction.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Aged 18 to 80 years, of any gender. 2. Scheduled for elective coronary angiography due to symptoms or evidence of myocardial ischemia. 3. Agreed to and capable of completing overnight polysomnography (PSG) monitoring. 4. Provided written informed consent and were willing and able to comply with baseline assessments and long-term follow-up. Exclusion Criteria: 1. Presence of coronary chronic total occlusion (CTO), history of coronary artery bypass grafting (CABG), severe valvular heart disease, dilated or hypertrophic cardiomyopathy, congenital heart disease, or heart failure (NYHA functional class III-IV). 2. Sleep-disordered breathing with central sleep apnea (CSA) as the primary manifestation. 3. Severe hepatic insufficiency (Child-Pugh class C) or renal failure (eGFR \< 30 mL/min/1.73 m²). 4. Pregnancy or lactation. 5. Life expectancy of less than 2 years, or any other condition that the investigators considered unsuitable for participation in the study.

Primary outcome measure(s)

the Prevalence of CMD Among Patients with OSA of Different Severities — at 6, 12, and 24 months after discharge
Differences in the Prevalence of Coronary Microvascular Dysfunction Among Patients with Obstructive Sleep Apnea of Different Severities

Trial sites (1)

Facility	City	Region	Status
Beijing Anzhen Hospital, Capital Medical University	Beijing	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07315399 on ClinicalTrials.gov ↗ ← All trials in China