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

NCT07315399 | Not Yet Recruiting

• 1 other identifier: BeijingAnzhen
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 2.To compare the predictive value of nocturnal hypoxemia parameters versus the traditional Apnea-Hypopnea Index (AHI) for coronary microvascular dysfunction.
3. 3.To evaluate the prognostic value of nocturnal hypoxemia parameters in predicting Major Adverse Cardiovascular Events (MACE) during the follow-up period.
4. 4.To explore the potential mediating roles of inflammatory and oxidative stress biomarkers in the relationship between nocturnal hypoxemia parameters and coronary microvascular dysfunction.

Conditions

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

Keywords

OSA - Obstructive Sleep Apnea; Coronary Microvascular Dysfunction; Coronary Artery Disease

Outcome Measures

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

  at 6, 12, and 24 months after discharge

Secondary Outcomes (1)

• The composite endpoint of major adverse cardiovascular events (MACE)

  At 6, 12, and 24 months after discharge

Interventions

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.

Also known as: Angiography-derived Index of Microvascular Resistance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Suspected myocardial ischemia patients underwent PSG to acquire detailed parameters of OSA-related nocturnal hypoxemia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Related Publications (1)

• Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available. Erratum In: Eur Heart J. 2020 Nov 21;41(44):4242. doi: 10.1093/eurheartj/ehz825.

  PMID: 31504439 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Coronary Artery Disease

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Chenchen Tu

CONTACT

+8615201648899; tcc2033@mail.ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)