Sleep Study-Guided Multidisciplinary Therapy for Patients Presenting With Acute Coronary Syndrome

NCT02599298 | Unknown

• 1 other identifier: NMRC CSA 2015
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized, open-label clinical trial is to determine the impact of Sleep Study-Guided Multidisciplinary Therapy (SGMT, i.e. continuous positive airway pressure and behavioral therapy) for obstructive sleep apnea (OSA) in the sub-acute phase of acute coronary syndrome on cardiovascular outcomes. We hypothesize that SGMT will result in a lower (1) plasma NT-pro BNP, ST2 levels and hs-CRP, (2) 10-year risk of cardiovascular mortality based on the European SCORE algorithm, and (3) cardiovascular event rate, when compared with Standard Therapy. OSA is an emerging cardiac risk factor and prognostic marker. We have reported that OSA is a prevalent and independent predictor of adverse outcomes in patients with acute coronary syndrome. In this clinical trial, a continuation of my research and publication trajectory, 180 patients presenting with acute coronary syndrome will be randomly assigned to SGMT (n=90) or Standard Therapy (n=90) groups. Both groups will receive guideline-mandated treatment for acute coronary syndrome. Those assigned to SGMT will undergo a sleep study. Those found to have OSA will attend the SGMT clinic run by a multidisciplinary team. Advice on continuous positive airway pressure and behavioral therapy (weight loss, exercise, positional therapy, abstinence of alcohol and sleeping pills) will be given. The primary endpoint is plasma NT-pro BNP concentration at 6-month follow-up. The secondary endpoints are ST2, hs-CRP, 10-year risk of cardiovascular mortality based on the European SCORE algorithm which includes age, sex, smoking status, systolic blood pressure, and serum total cholesterol or total/HDL-cholesterol ratio. Adverse cardiovascular events at 3-year follow-up will be determined. In our aging population with an increasing prevalence of obesity, OSA will potentially become an increasingly important contributor to cardiovascular disease. Leveraging the collective expertise of a team of cardiologists and sleep physicians, our work will benefit society by advancing our understanding of the cardiovascular benefits of screening for and treating OSA.

Conditions

Obstructive Sleep Apnea; Acute Coronary Syndrome

Keywords

sleep; treatment

Outcome Measures

Primary Outcomes (1)

• Plasma concentration of NT-proBNP

  6-month

Secondary Outcomes (4)

• European cardiovascular risk SCORE

  6-month

• Composite clinical endpoint of cardiovascular death, myocardial infarction (Q-wave and non-Q wave), stroke, unplanned revascularization, and hospitalization for heart failure

  12-month

• Plasma concentration of ST2

  6-month

• Plasma concentration of hs-CRP

  6-month

Other Outcomes (1)

• Compliance to CPAP

  6-month

Study Arms (2)

SGMT arm

ACTIVE COMPARATOR

Treatment of OSA requires a multidisciplinary approach, involving a sleep physician and paramedical staff with expertise in the management of sleep disorders. An initial medical assessment is needed to confirm the diagnosis of OSA, determine its severity and decide whether CPAP therapy is appropriate. As part of this evaluation, an objective overnight sleep study will be performed. This will be followed by an assessment, education, and counseling at the multidisciplinary therapy clinic.

Device: Continuous Positive Airway Therapy; Behavioral: Sleep-Study Guided Multidisciplinary Therapy

Control arm

NO INTERVENTION

The patients will be treated according to the standard treatment for acute coronary syndrome in Singapore, which is largely in accordance with the recommendations of the American College of Cardiology and the American Heart Association. Management includes, but is not limited to, antiplatelet and lipid-lowering therapy, early coronary revascularization, and cardiac rehabilitation, with the recommendation to follow the current practice and the most recent international guidelines.

Interventions

Continuous Positive Airway Therapy DEVICE

Also known as: CPAP

SGMT arm

Sleep-Study Guided Multidisciplinary Therapy BEHAVIORAL

SGMT arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 21 years, admission with an acute coronary syndrome, competent informed consent, and the ability to follow all protocol procedures.

You may not qualify if:

• Known OSA being treated by CPAP, recommended coronary artery bypass surgery, concomitant moderate to severe structural valve disease, clinical instability (decompensated hypotension, heart failure, shock, refractory ventricular arrhythmias, acute conduction system disease, implanted defibrillator, or left ventricular ejection fraction ≤ 30%), limited life expectancy (\< 1 year) due to a concomitant illness, prior or planned heart transplant or any other organ transplant, pregnancy or current nursing activity, or inability to give informed consent.

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Chi-Hang Lee

Singapore, 119228, Singapore

Location

Related Publications (1)

• Koo CY, Chua AP, Kristanto W, Koh EH, Tan ES, Abd Rahman S, Abd Gani MB, Chong JP, Aung AT, Han TO, Chan SP, Low AF, Yeo TC, Chan MY, Kojodjojo P, Richards AM, Lee CH. Screening and treatment of obstructive sleep apnea in acute coronary syndrome. A randomized clinical trial. Int J Cardiol. 2020 Jan 15;299:20-25. doi: 10.1016/j.ijcard.2019.07.003. Epub 2019 Jul 3.

  PMID: 31307844 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: July 11, 2016
• Primary Completion: September 20, 2018
• Study Completion: December 1, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

SG (1)