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

China560 participantsStarted 2025-12-30

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Aged 18 to 80 years, of any gender.
✓. Scheduled for elective coronary angiography due to symptoms or evidence of myocardial ischemia.
✓. Agreed to and capable of completing overnight polysomnography (PSG) monitoring.
✓. Provided written informed consent and were willing and able to comply with baseline assessments and long-term follow-up.

Exclusion criteria

✕. 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).
✕. Sleep-disordered breathing with central sleep apnea (CSA) as the primary manifestation.
✕. Severe hepatic insufficiency (Child-Pugh class C) or renal failure (eGFR \< 30 mL/min/1.73 m²).
✕. Pregnancy or lactation.
✕. Life expectancy of less than 2 years, or any other condition that the investigators considered unsuitable for participation in the study.

What they're measuring

the Prevalence of CMD Among Patients with OSA of Different Severities

Timeframe: at 6, 12, and 24 months after discharge

Trial details

NCT IDNCT07315399

SponsorBeijing Anzhen Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-30

Contact for this trial

Chenchen Tu

+8615201648899 tcc2033@mail.ccmu.edu.cn

View on ClinicalTrials.gov More OSA - Obstructive Sleep Apnea trials