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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBeijing Anzhen Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Polysomnography

    Diagnostic test

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
at 6, 12, and 24 months after discharge

Secondary outcomes

1

The composite endpoint of major adverse cardiovascular events (MACE)

including cardiac death, non-fatal myocardial infarction, and rehospitalization for unstable angina or heart failure.

Time frame
At 6, 12, and 24 months after discharge

Other outcomes

Sponsors and contacts

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