Sleep and Stent Study: a Multicentre, Prospective Study

NCT02215317 | Completed DMC

• 1 other identifier: SSS
• Study Type: observational
• Target: 1,815
• Locations: 1 country
• Sites: 1

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 is a multi-center observational study investigating the relationships between OSA and cardiovascular outcomes in patients treated with percutaneous coronary intervention (PCI).

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea; Stent; Coronary Artery Disease; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Major Adverse Cardiac and Cerebrovascular events (MACCE)

  Cardiovascular Death, Myocardial Infarction, Stroke/TIA, Unplanned revascularization

  Two years

Secondary Outcomes (1)

• Number of Participants with Adverse Events other than MACCE

  Two years

Study Arms (2)

OSA group

Patients found to have OSA based on an overnight sleep study

Non-OSA group

Patients found not to have OSA based on an overnight sleep study

Eligibility Criteria

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

Study Population

This is a prospective, observational multi-national cohort study of patients undergoing PCI for coronary artery disease. Adult patients undergoing clinically indicated PCI for coronary artery disease will be enrolled in the Sleep and Stent Study.

You may qualify if:

• Age ≥18 years old and \< 80 years old
• Successful PCI to at least one of the epicardial coronary arteries

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University of Singapore: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Venesa Loh

Singapore, 119228, Singapore

Location

Related 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. doi: 10.1002/clc.22261.

  PMID: 24945037 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Chi-Hang Lee, MD

  National University Heart Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 13, 2014
• Study Start: December 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

SG (1)