Sleep and Stent Study: a Multicentre, Prospective Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Impact of Obstructive Sleep Apnea on Cardiovascular Outcomes in Patients Treated With Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215317
• Other study ID #: SSS
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: February 22, 2017
• Start date: December 2011
• Est. completion date: September 2015

Study information

• Verified date: February 2017
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is crucial in risk assessments and therapeutic recommendations for affected individuals. The Sleep and Stent Study is a multi-center observational study investigating the relationships between OSA and cardiovascular outcomes in patients treated with percutaneous coronary intervention (PCI).

Description:

Preliminary data suggest that OSA may lead to adverse cardiovascular outcomes after PCI. However, existing data were generated from small-scale, single-center studies. Therefore, in the Sleep and Stent Study, the investigators aim to conduct a large-scale multi-national cohort study to determine the association between OSA and the incidence of adverse cardiovascular outcomes over a long-term follow-up period. The investigators hypothesize that OSA is an independent risk factor for the development of major adverse cardiovascular and cerebrovascular events (MACCEs) in coronary artery disease patients treated with PCI. Results from the Sleep and Stent Study will advance the fundamental understanding of the burden and prognostic implications of OSA in patients undergoing PCI for coronary artery disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1815
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age =18 years old and < 80 years old

• Successful PCI to at least one of the epicardial coronary arteries

Exclusion Criteria:

• Known OSA on CPAP treatment

• Intubation for mechanical ventilation

• Intra-aortic balloon pump or other hemodynamic support device

• Sedation or other muscle relaxant given before overnight sleep study

• Perceived high risk of malignant ventricular arrhythmia

• Cardiogenic shock with systolic blood pressure <90 mmHg

• Clinical heart failure requiring oxygen supplementation

• Pregnancy

• History of malignancy (except non-melanoma skin cancer, cervical in-situ carcinoma, breast ductal carcinoma in situ or stage 1 prostate carcinoma)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Singapore	Venesa Loh	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University, Singapore	Boston Scientific Corporation

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Loo G, Koo CY, Zhang J, Li R, Sethi R, Ong TH, Tai BC, Lee CH. Impact of obstructive sleep apnea on cardiovascular outcomes in patients treated with percutaneous coronary intervention: rationale and design of the sleep and stent study. Clin Cardiol. 2014 May;37(5):261-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)	Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization	Two years
Secondary	Number of Participants with Adverse Events other than MACCE	All-cause mortality, Target vessel revascularization, Stent thrombosis, Hospitalization for heart failure.	Two years