Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02599298 |
| Other study ID # |
NMRC CSA 2015 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 11, 2016 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
October 2020 |
| Source |
National University, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Acute coronary syndrome is a leading cause of mortality and morbidity globally. The Principal
Investigator (PI) has been conducting research on sleep medicine and cardiovascular disease
since 2007. Our early work has shown that obstructive sleep apnea (OSA) is prevalent in
patients presenting with an acute coronary syndrome, and carries negative prognostic
implications. This Clinician Scientist Award application is centered on the potential
cardiovascular benefits of a Sleep Study-Guided Multidisciplinary Therapy (SGMT) that
includes continuous positive airway pressure (CPAP) and behavioral therapy for patients
presenting with an acute coronary syndrome, which could lead to a potential paradigm shift in
patient management during the sub-acute phase of the syndrome. For this application, we have
assembled a team of experts in cardiovascular medicine and sleep medicine. Using the leverage
of the synergistic expertise of the assembled leaders and the knowledge generated in the
early part of the program, we will embark on a therapeutic trial.
In this randomized trial, 180 patients presenting with an acute coronary syndrome will be
recruited and randomized into SGMT versus standard therapy (without sleep study) groups. Both
groups will be treated with a guideline-mandated therapy for acute coronary syndrome
(including regular cardiology outpatient clinic visits after discharge). In those allocated
to SGMT, an overnight sleep study using a level 3 portable diagnostic device will be carried
out. Those with OSA (an estimated 75% according to the pilot data) will be treated with CPAP
and behavioral therapy. Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), ST2, and
hs-CRP levels will be measured before hospital discharge and at 6-month follow-up. The
10-year risk of cardiovascular mortality based on the European cardiovascular risk score
(SCORE), which includes age, sex, smoking status, systolic blood pressure, and serum total
cholesterol or total/high-density lipoprotein (HDL)-cholesterol ratio, will be determined at
baseline and at 6-month follow-up.
Our specific aims are to compare the effects of SGMT and standard therapy on:
- Plasma levels of NT-proBNP (Primary endpoint), ST2 and hs-CRP. We hypothesize that SGMT
will be associated with a lower plasma NT-proBNP, ST2 and hs-CRP levels than standard
therapy at 6-month follow-up.
- Systematic COronary Risk Evaluation (SCORE). We hypothesize that SGMT will be associated
with a lower SCORE than standard therapy at 6-month follow-up.
- Incidence of major adverse cardiac events (extended study). We hypothesize that SGMT
will be associated with a lower incidence of major adverse cardiac events at 3-year
follow-up (an application for additional funding will be made to accomplish this aim).
