Acute Coronary SyndromeISAACCNCT01335087
Continuous Positive Airway Pressure (CPAP) in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA)
A study testing continuous positive airway pressure in people with Acute Coronary Syndrome and Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Obstructive Sleep Apnea
- What is being tested?
- continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,864 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2011to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Sleep Apnea Syndrome in the Evolution of Acute Coronary Syndrome. Effect of Intervention With Continuous Positive Airway Pressure (CPAP). A Prospective Randomized Study. ISAACC Study
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:
Read more
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:
- 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:
- Determine the prevalence of OSA in patients who have suffered an episode of ACS.
- Other secondary objectives will include the effects of CPAP on:
- 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.
Read the detailed description
Methods:
Study design: multi-centre, open label, parallel, prospective, randomised, controlled trial.
Patients: We will include consecutive patients with an ACS diagnosis evaluated in participating Coronary Care Unit.
Study sites: IRB Lleida (Lleida), Hospital Son Dureta (Palma de Mallorca), Hospital Clínic (Barcelona), Hospital Germans Tries i Pujol (Barcelona), Hospital de Bellvitge (Barcelona), Hospital Sant Pau (Barcelona), Hospital Txagorritxu (Vitoria), Hospital de Cruces (Bilbao), Hospital San Pedro de Alcántara (Cáceres), Hospital Parc Taulí (Barcelona) and Hospital de Guadalajara (Guadalajara), Hospital de Vallecas (Madrid), Hospital de Yagüe (Burgos), Hospital de Requena (Valencia), Hospital San Juan, (Alicante), Hospital Central de Asturias (Oviedo).
Duration of the study: 3 years. Methodology: During a hospital stay we will assess the degree of daytime sleepiness (Epworth Scale) in patients treated at the Coronary Care Unit with a diagnosis of ACS. The results of this evaluation will define the inclusion of the patient in the study.
Patients with and ESS score ≤ 10 will be included in the study and will undergo a cardio-respiratory polygraphy. Patients with an AHI ≥ 15 h-1 will be randomized to CPAP treatment or conservative. Patients with and AHÍ < 15 h-1 will be followed as standard management according to cardiovascular protocols and will be evaluated as a reference group. Therefore, the study will have three groups, with a total of 1,864 patients, as follows: patients with an AHI ≥ 15 h-1 will be randomized to CPAP treatment (Group 1) (n=632) or conservative treatment (Group 2) (n=632). Patients with an AHI < 15 h-1 that will be followed as a reference group (Group 3) (n=600).
Patients with an ESS score higher than 10 will be excluded of the study and referred to the sleep unit of each participating center for evaluation.
Patients included in the study will be monitored and followed for a minimum of one year and a maximum of three years. Patients will be examined at the time of inclusion (T0), after one month (T1), three months (T2), six months (T3), 12 months (T4) and every six months thereafter, if applicable, during the follow-up period. Evaluations will include; i)new episodes of ACS, stroke, TIA, heart failure, hospitalization for cardiovascular causes and cardiovascular mortality, ii) biological risk markers involved in cardiovascular complications, iii) an evaluation of the cost-effectiveness of diagnosis and CPAP treatment in patients with ACS who have obstructive sleep apnea.
- Conditions
- Acute Coronary Syndrome, Obstructive Sleep Apnea
- Being tested
- Standard care, continuous positive airway pressure
- Keywords
- sleep apnea, secondary prevention, cardiovascular endpoint
- Medical subject headings
- Acute Coronary Syndrome, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle | Active comparator | Standard care for OSA: lifestyle, and sleep hygiene counselling Receives: Other: Standard care |
| Continuous positive airway pressure CPAP | Experimental | CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling Receives: Other: Standard care; Device: continuous positive airway pressure |
| Reference | No intervention | This group will be followed according to cardiovascular protocols and will be evaluated as a reference group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month after the inclusion of the last patient
Secondary outcomes (12)
Prevalence of OSA in patients who have suffered an episode of ACS.
Determined at the inclusion of the patient
Measured: 24 month (inclusion period)
Composite of major CV events
CV death, myocardial infarction (MI) and ischaemic stroke.
Measured: 12 month after the inclusion of the last patient
Components of primary composite endpoints separately.
Cardiovascular events are: cardiovascular death, non-fatal AMI, non-fatal stroke, hospital admission for heart failure, and new hospitalization for unstable angina or TIA.
Measured: 12 month after the inclusion of the last patient
Number of re-vascularization procedures.
Revascularisation procedures, including PCI, CABG, peripheral arterial revascularisation and intra-cerebral stent insertion
Measured: 12 month after the inclusion of the last patient
All-cause mortality.
All-cause mortality.
Measured: 12 month after the inclusion of the last patient
New onset of ECG-confirmed atrial fibrillation or other arrhythmias.
ECGs were performed at baseline and during the follow-up period; ECG and medical records were collected tovconfirm a hospitalization for atrial fibrillation event
Measured: 12 month after the inclusion of the last patient
Newly diagnosed diabetes mellitus, according to standard definitions.
Newly diagnosed diabetes mellitus, according to standard definitions
Measured: 12 month after the inclusion of the last patient
Epworth Sleepiness Scale (ESS) and Test EuroQol (EQ-5D).
OSA symptoms: Epworth Sleepiness Scale (ESS). Quality of life: Test EuroQol (EQ-5D).
Measured: 12 month after the inclusion of the last patient
Severity and phenotype of patients with OSA and clinical outcomes of ACS.
To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS.
Measured: 12 month after the inclusion of the last patient
CPAP compliance and CV events incidence.
To establish the relationship between CPAP compliance and CV events incidence.
Measured: 12 month after the inclusion of the last patient
Biological risk markers related to mechanisms involved in cardiovascular complications in these patients.
To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients.
Measured: 12 month after the inclusion of the last patient
Cost-effectiveness analysis (Qualys) of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.
Cost-effectiveness analysis (Qualys) of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea
Measured: 12 month after the inclusion of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,864 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed, Fondo de Investigacion Sanitaria, EsteveTeijin Healthcare, Spanish Society of Cardiology, Sociedad Madrileña de Neumologia
- Responsible party
- Principal investigator, Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Ferran Barbe, MD, Principal investigator, Spanish Respiratory Sociey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335087
- Sponsor's protocol ID
- PI10/02763
- Acronym
- ISAACC
- Status last verified
- Oct 2018
- First submitted
- 5 Apr 2011
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dodani K, Aldoma A, Targa A, Sanchez-de-la-Torre M, Sanchez-de-la-Torre A, Pinilla L, Abad J, Minguez O, Pascual L, Martinez D, Vaca R, Juez-Garcia I, Barbe F, Benitez ID. OSA and Acute Coronary Syndrome Severity: The Potential Role of Coronary Collateral Circulation. Chest. 2026 Mar 7:S0012-3692(26)00288-6. doi: 10.1016/j.chest.2026.02.015. Online ahead of print.
PubMed 41802590Sanchez-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.
PubMed 37787793Pinilla 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.
PubMed 37734857Sanchez-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.
PubMed 35442180Reynor 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.
PubMed 34739082Sanchez-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.
PubMed 31839558Bauca 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.
PubMed 30928393Bauca 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.
PubMed 28419383Barcelo 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.
PubMed 26930634Torres 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.
PubMed 25879807Barbe 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.
PubMed 25573410Esquinas 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.
PubMed 23843147
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Apnea Syndrome in the Evolution of Acute Coronary Syndrome. Effect of Intervention With Continuous Positive Airway Pressure (CPAP). A Prospective Randomized Study. ISAACC Study
- ClinicalTrials.gov ID
- NCT01335087
- Acronym / sponsor ID
- ISAACC / PI10/02763
- Conditions
- Acute Coronary Syndrome, Obstructive Sleep Apnea
- Keywords
- sleep apnea, secondary prevention, cardiovascular endpoint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,864 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Collaborators
- ResMed, Fondo de Investigacion Sanitaria, EsteveTeijin Healthcare, Spanish Society of Cardiology, Sociedad Madrileña de Neumologia
- Study start
- Apr 2011
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Determine the prevalence of OSA in patients who have suffered an episode of ACS.
- Other secondary objectives will include the effects of CPAP on:
- 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.
Detailed description
Methods:
Study design: multi-centre, open label, parallel, prospective, randomised, controlled trial.
Patients: We will include consecutive patients with an ACS diagnosis evaluated in participating Coronary Care Unit.
Study sites: IRB Lleida (Lleida), Hospital Son Dureta (Palma de Mallorca), Hospital Clínic (Barcelona), Hospital Germans Tries i Pujol (Barcelona), Hospital de Bellvitge (Barcelona), Hospital Sant Pau (Barcelona), Hospital Txagorritxu (Vitoria), Hospital de Cruces (Bilbao), Hospital San Pedro de Alcántara (Cáceres), Hospital Parc Taulí (Barcelona) and Hospital de Guadalajara (Guadalajara), Hospital de Vallecas (Madrid), Hospital de Yagüe (Burgos), Hospital de Requena (Valencia), Hospital San Juan, (Alicante), Hospital Central de Asturias (Oviedo).
Duration of the study: 3 years. Methodology: During a hospital stay we will assess the degree of daytime sleepiness (Epworth Scale) in patients treated at the Coronary Care Unit with a diagnosis of ACS. The results of this evaluation will define the inclusion of the patient in the study.
Patients with and ESS score ≤ 10 will be included in the study and will undergo a cardio-respiratory polygraphy. Patients with an AHI ≥ 15 h-1 will be randomized to CPAP treatment or conservative. Patients with and AHÍ < 15 h-1 will be followed as standard management according to cardiovascular protocols and will be evaluated as a reference group. Therefore, the study will have three groups, with a total of 1,864 patients, as follows: patients with an AHI ≥ 15 h-1 will be randomized to CPAP treatment (Group 1) (n=632) or conservative treatment (Group 2) (n=632). Patients with an AHI < 15 h-1 that will be followed as a reference group (Group 3) (n=600).
Patients with an ESS score higher than 10 will be excluded of the study and referred to the sleep unit of each participating center for evaluation.
Patients included in the study will be monitored and followed for a minimum of one year and a maximum of three years. Patients will be examined at the time of inclusion (T0), after one month (T1), three months (T2), six months (T3), 12 months (T4) and every six months thereafter, if applicable, during the follow-up period. Evaluations will include; i)new episodes of ACS, stroke, TIA, heart failure, hospitalization for cardiovascular causes and cardiovascular mortality, ii) biological risk markers involved in cardiovascular complications, iii) an evaluation of the cost-effectiveness of diagnosis and CPAP treatment in patients with ACS who have obstructive sleep apnea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle | Active comparator | Other: Standard careStandard care for OSA: lifestyle, and sleep hygiene counselling |
| Continuous positive airway pressure CPAP | Experimental | Other: Standard care, Device: continuous positive airway pressureCPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling |
| Reference | No intervention | –This group will be followed according to cardiovascular protocols and will be evaluated as a reference group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard carePatients 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. | Other | Continuous positive airway pressure CPAP, Lifestyle |
| continuous positive airway pressurePatients 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. | Device | Continuous positive airway pressure CPAP |
Primary outcome
Rate of cardiovascular events in patients with acute coronary syndrome and co-occurring sleep apnea.
Time frame: 12 month after the inclusion of the last patient
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 secondary outcomes
Prevalence of OSA in patients who have suffered an episode of ACS.
Time frame: 24 month (inclusion period)
Composite of major CV events
Time frame: 12 month after the inclusion of the last patient
Components of primary composite endpoints separately.
Time frame: 12 month after the inclusion of the last patient
Number of re-vascularization procedures.
Time frame: 12 month after the inclusion of the last patient
All-cause mortality.
Time frame: 12 month after the inclusion of the last patient
New onset of ECG-confirmed atrial fibrillation or other arrhythmias.
Time frame: 12 month after the inclusion of the last patient
Newly diagnosed diabetes mellitus, according to standard definitions.
Time frame: 12 month after the inclusion of the last patient
Epworth Sleepiness Scale (ESS) and Test EuroQol (EQ-5D).
Time frame: 12 month after the inclusion of the last patient
Severity and phenotype of patients with OSA and clinical outcomes of ACS.
Time frame: 12 month after the inclusion of the last patient
CPAP compliance and CV events incidence.
Time frame: 12 month after the inclusion of the last patient
Biological risk markers related to mechanisms involved in cardiovascular complications in these patients.
Time frame: 12 month after the inclusion of the last patient
Cost-effectiveness analysis (Qualys) of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.
Time frame: 12 month after the inclusion of the last patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 41802590Dodani K, Aldoma A, Targa A, Sanchez-de-la-Torre M, Sanchez-de-la-Torre A, Pinilla L, Abad J, Minguez O, Pascual L, Martinez D, Vaca R, Juez-Garcia I, Barbe F, Benitez ID. OSA and Acute Coronary Syndrome Severity: The Potential Role of Coronary Collateral Circulation. Chest. 2026 Mar 7:S0012-3692(26)00288-6. doi: 10.1016/j.chest.2026.02.015. Online ahead of print.
- Derived from this study: PubMed 37787793Sanchez-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.
- Derived from this study: PubMed 37734857Pinilla 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.
- Derived from this study: PubMed 35442180Sanchez-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.
- Derived from this study: PubMed 34739082Reynor 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.
- Derived from this study: PubMed 31839558Sanchez-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.
- Derived from this study: PubMed 30928393Bauca 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.
- Derived from this study: PubMed 28419383Bauca 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.
- Derived from this study: PubMed 26930634Barcelo 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.
- Derived from this study: PubMed 25879807Torres 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.
- Derived from this study: PubMed 25573410Barbe 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.
- Derived from this study: PubMed 23843147Esquinas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ferran Barbe, MD principal investigator
Spanish Respiratory Sociey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure in people with Acute Coronary Syndrome and Obstructive Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cardiovascular events in patients with acute coronary syndrome and co-occurring sleep apnea. (time frame: 12 month after the inclusion of the last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01335087, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.