NCT01335087

Brief Summary

OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure and other risk factors for cardiovascular disease. The overall aim of ISAACC is to determine if CPAP can reduce the risk of heart attack, stroke or heart failure for people with OSA admitted in a hospital for an acute coronary syndrome. Overall objective: To assess the impact of obstructive sleep apnea (OSA) and its treatment on the clinical evolution of patients with acute coronary syndrome (ACS). Primary objectives: 1\. To determine if continuous positive airway pressure (CPAP) treatment will reduce the rate of cardiovascular events (cardiovascular (CV) death, non-fatal events (acute myocardial infarction (AMI), non-fatal stroke, hospital admission for heart failure, and new hospitalizations) for unstable angina or transient ischaemic attack (TIA)) in patients with ACS and co-occurring sleep apnea. Secondary objectives:

  • To evaluate a composite of CV death, myocardial infarction (MI) and ischaemic stroke.
  • Components of primary composite endpoints
  • Re-vascularization procedures
  • To evaluate all-cause death
  • To evaluate new onset, ECG-confirmed atrial fibrillation or other arrhythmias
  • To evaluate newly diagnosed diabetes mellitus, according to standard definitions
  • To evaluate OSA symptoms (Epworth Sleepiness Scale (ESS))
  • To evaluate quality of life in patients with ACS (Test EuroQol (EQ-5D).
  • To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS.
  • To establish the relationship between CPAP compliance and CV events incidence.
  • To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients.
  • To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,864

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

7.4 years

First QC Date

April 5, 2011

Last Update Submit

October 25, 2018

Conditions

Acute Coronary SyndromeObstructive Sleep Apnea

Keywords

sleep apneasecondary preventioncardiovascular endpoint

Outcome Measures

Primary Outcomes (1)

  • Rate of cardiovascular events in patients with acute coronary syndrome and co-occurring sleep apnea.

    Cardiovascular events are: cardiovascular death, non-fatal AMI, non-fatal stroke, hospital admission for heart failure, and new hospitalization for unstable angina or TIA.

    12 month after the inclusion of the last patient

Secondary Outcomes (12)

  • Prevalence of OSA in patients who have suffered an episode of ACS.

    24 month (inclusion period)

  • Composite of major CV events

    12 month after the inclusion of the last patient

  • Components of primary composite endpoints separately.

    12 month after the inclusion of the last patient

  • Number of re-vascularization procedures.

    12 month after the inclusion of the last patient

  • All-cause mortality.

    12 month after the inclusion of the last patient

  • +7 more secondary outcomes

Study Arms (3)

Lifestyle

ACTIVE COMPARATOR

Standard care for OSA: lifestyle, and sleep hygiene counselling

Other: Standard care

Continuous positive airway pressure CPAP

EXPERIMENTAL

CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling

Other: Standard careDevice: continuous positive airway pressure

Reference

NO INTERVENTION

This group will be followed according to cardiovascular protocols and will be evaluated as a reference group.

Interventions

Standard careOTHER

Patients with conservative treatment: (Group 2). This group will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counselling.

Continuous positive airway pressure CPAPLifestyle
continuous positive airway pressureDEVICE

Patients with CPAP treatment (Group 1): CPAP pressure titration will be performed by automated equipment before discharge. It will follow the methodology described by our group (Mass et al. Alternative Methods of titrating continuous positive airway pressure: a large multicentre study. American Journal of Respiratory and Critical Care Medicine (2004) vol. 170 (11) pp. 1218-1224). This group will also be instructed in hygienic-dietary measures recommended for all patients, standard care of cardiovascular risk factors and sleep hygiene counselling.

Continuous positive airway pressure CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 18 years old.
  • Patients admitted for documented symptoms of ACS with or without T segment elevation and have an hospital stay between 24h and 72 h in the moment to perform polygraphy .
  • Patients with and Epworth Sleep Scale score ≤ 10 (patients without excessive daytime sleepiness).
  • Written informed consent signed.

You may not qualify if:

  • Previous CPAP treatment for OSA diagnosis
  • Psycho-physical inability to complete questionnaires.
  • Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
  • Patients with \> 50% of central apneas or the presence of Cheyne-Stokes Respiration (CSResp)
  • Patients with chronic diseases: neoplasia, renal failure (GFR\<30 ml/min), severe chronic obstructive pulmonary disease, chronic depression and other very limiting chronic diseases.
  • A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
  • Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).
  • Any process, cardiovascular or otherwise, that limits life expectancy to less than one year.
  • Patients in cardiogenic shock who have poor expectations for short-term outcomes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spanish Respiratory Society

Barcelona, 08009, Spain

Location

Related Publications (11)

  • Sanchez-de-la-Torre M, Gracia-Lavedan E, Benitez ID, Sanchez-de-la-Torre A, Moncusi-Moix A, Torres G, Loffler K, Woodman R, Adams R, Labarca G, Dreyse J, Eulenburg C, Thunstrom E, Glantz H, Peker Y, Anderson C, McEvoy D, Barbe F. Adherence to CPAP Treatment and the Risk of Recurrent Cardiovascular Events: A Meta-Analysis. JAMA. 2023 Oct 3;330(13):1255-1265. doi: 10.1001/jama.2023.17465.

    PMID: 37787793DERIVED

  • Pinilla L, Esmaeili N, Labarca G, Martinez-Garcia MA, Torres G, Gracia-Lavedan E, Minguez O, Martinez D, Abad J, Masdeu MJ, Mediano O, Munoz C, Cabriada V, Duran-Cantolla J, Mayos M, Coloma R, Montserrat JM, de la Pena M, Hu WH, Messineo L, Sehhati M, Wellman A, Redline S, Sands S, Barbe F, Sanchez-de-la-Torre M, Azarbarzin A. Hypoxic burden to guide CPAP treatment allocation in patients with obstructive sleep apnoea: a post hoc study of the ISAACC trial. Eur Respir J. 2023 Dec 7;62(6):2300828. doi: 10.1183/13993003.00828-2023. Print 2023 Dec.

    PMID: 37734857DERIVED

  • Sanchez-de-la-Torre M, Gracia-Lavedan E, Benitez ID, Zapater A, Torres G, Sanchez-de-la-Torre A, Aldoma A, de Batlle J, Targa A, Abad J, Duran-Cantolla J, Urrutia A, Mediano O, Masdeu MJ, Ordax-Carbajo E, Masa JF, De la Pena M, Mayos M, Coloma R, Montserrat JM, Chiner E, Minguez O, Pascual L, Cortijo A, Martinez D, Dalmases M, Lee CH, McEvoy RD, Barbe F; Spanish Sleep Network. Long-Term Effect of Obstructive Sleep Apnea and Continuous Positive Airway Pressure Treatment on Blood Pressure in Patients with Acute Coronary Syndrome: A Clinical Trial. Ann Am Thorac Soc. 2022 Oct;19(10):1750-1759. doi: 10.1513/AnnalsATS.202203-260OC.

    PMID: 35442180DERIVED

  • Reynor A, McArdle N, Shenoy B, Dhaliwal SS, Rea SC, Walsh J, Eastwood PR, Maddison K, Hillman DR, Ling I, Keenan BT, Maislin G, Magalang U, Pack AI, Mazzotti DR, Lee CH, Singh B. Continuous positive airway pressure and adverse cardiovascular events in obstructive sleep apnea: are participants of randomized trials representative of sleep clinic patients? Sleep. 2022 Apr 11;45(4):zsab264. doi: 10.1093/sleep/zsab264.

    PMID: 34739082DERIVED

  • Sanchez-de-la-Torre M, Sanchez-de-la-Torre A, Bertran S, Abad J, Duran-Cantolla J, Cabriada V, Mediano O, Masdeu MJ, Alonso ML, Masa JF, Barcelo A, de la Pena M, Mayos M, Coloma R, Montserrat JM, Chiner E, Perello S, Rubinos G, Minguez O, Pascual L, Cortijo A, Martinez D, Aldoma A, Dalmases M, McEvoy RD, Barbe F; Spanish Sleep Network. Effect of obstructive sleep apnoea and its treatment with continuous positive airway pressure on the prevalence of cardiovascular events in patients with acute coronary syndrome (ISAACC study): a randomised controlled trial. Lancet Respir Med. 2020 Apr;8(4):359-367. doi: 10.1016/S2213-2600(19)30271-1. Epub 2019 Dec 12.

    PMID: 31839558DERIVED

  • Bauca JM, Barcelo A, Fueyo L, Sanchis P, Pierola J, de la Pena M, Arque M, Gomez C, Morell-Garcia D, Sanchez-de-la-Torre A, Sanchez-de-la-Torre M, Abad J, Duran-Cantolla J, Mediano O, Masdeu MJ, Urrutia-Gajate A, Masa JF, Barbe F; Spanish Sleep Group. Biomarker panel in sleep apnea patients after an acute coronary event. Clin Biochem. 2019 Jun;68:24-29. doi: 10.1016/j.clinbiochem.2019.03.015. Epub 2019 Mar 28.

    PMID: 30928393DERIVED

  • Bauca JM, Yanez A, Fueyo L, de la Pena M, Pierola J, Sanchez-de-la-Torre A, Mediano O, Cabriada-Nuno V, Masdeu MJ, Teran-Santos J, Duran-Cantolla J, Masa JF, Abad J, Sanchez-de-la-Torre M, Barbe F, Barcelo A; Spanish Sleep Network. Cell Death Biomarkers and Obstructive Sleep Apnea: Implications in the Acute Coronary Syndrome. Sleep. 2017 May 1;40(5). doi: 10.1093/sleep/zsx049.

    PMID: 28419383DERIVED

  • Barcelo A, Bauca JM, Yanez A, Fueyo L, Gomez C, de la Pena M, Pierola J, Rodriguez A, Sanchez-de-la-Torre M, Abad J, Mediano O, Amilibia J, Masdeu MJ, Teran J, Montserrat JM, Mayos M, Sanchez-de-la-Torre A, Barbe F; Spanish Sleep Group. Impact of Obstructive Sleep Apnea on the Levels of Placental Growth Factor (PlGF) and Their Value for Predicting Short-Term Adverse Outcomes in Patients with Acute Coronary Syndrome. PLoS One. 2016 Mar 1;11(3):e0147686. doi: 10.1371/journal.pone.0147686. eCollection 2016.

    PMID: 26930634DERIVED

  • Torres G, Sanchez-de-la-Torre M, Barbe F. Relationship Between OSA and Hypertension. Chest. 2015 Sep;148(3):824-832. doi: 10.1378/chest.15-0136.

    PMID: 25879807DERIVED

  • Barbe F, Sanchez-de-la-Torre A, Abad J, Duran-Cantolla J, Mediano O, Amilibia J, Masdeu MJ, Flores M, Barcelo A, de la Pena M, Aldoma A, Worner F, Valls J, Castella G, Sanchez-de-la-Torre M; Spanish Sleep Network. Effect of obstructive sleep apnoea on severity and short-term prognosis of acute coronary syndrome. Eur Respir J. 2015 Feb;45(2):419-27. doi: 10.1183/09031936.00071714. Epub 2015 Jan 8.

    PMID: 25573410DERIVED

  • Esquinas C, Sanchez-de-la Torre M, Aldoma A, Flores M, Martinez M, Barcelo A, Barbe F; Spanish Sleep Network. Rationale and methodology of the impact of continuous positive airway pressure on patients with ACS and nonsleepy OSA: the ISAACC Trial. Clin Cardiol. 2013 Sep;36(9):495-501. doi: 10.1002/clc.22166. Epub 2013 Jul 10.

    PMID: 23843147DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeSleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

Standard of CareContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationPositive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Ferran Barbe, MD

    Spanish Respiratory Sociey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 14, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

ES(1)