About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Suspected myocardial ischemia patients underwent PSG to acquire detailed parameters of OSA-related nocturnal hypoxemia.
Trial design
Cohort
Prospective
Treatments tested in this trial
Polysomnography
Diagnostic test1. 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.
Treatment groups
Trial outcomes
Primary outcomes
the Prevalence of CMD Among Patients with OSA of Different Severities
Differences in the Prevalence of Coronary Microvascular Dysfunction Among Patients with Obstructive Sleep Apnea of Different Severities
Secondary outcomes
The composite endpoint of major adverse cardiovascular events (MACE)
including cardiac death, non-fatal myocardial infarction, and rehospitalization for unstable angina or heart failure.
Sponsors and contacts
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