Status:
COMPLETED
Sleep and Stent Study: a Multicentre, Prospective Study
Lead Sponsor:
National University of Singapore
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-80 years
Brief 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 i...
Detailed 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 Sten...
Eligibility Criteria
Inclusion
- Age ≥18 years old and \< 80 years old
- Successful PCI to at least one of the epicardial coronary arteries
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
1815 Patients enrolled
Trial Details
Trial ID
NCT02215317
Start Date
December 1 2011
End Date
September 1 2015
Last Update
February 23 2017
Active Locations (1)
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1
Venesa Loh
Singapore, Singapore, 119228