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Continuous Positive Airway Pressure (CPAP) in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea (OSA) (ISAACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01335087
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : October 29, 2018
Sponsor:
Collaborators:
ResMed
Fondo de Investigacion Sanitaria
EsteveTeijin Healthcare
Societat Catalana de Cardiologia
Sociedad Madrileña de Neumologia
Information provided by (Responsible Party):
Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica

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:

  1. Determine the prevalence of OSA in patients who have suffered an episode of ACS.
  2. 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).
  3. To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS.
  4. To establish the relationship between CPAP compliance and CV events incidence.
  5. To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients.
  6. To conduct a cost-effectiveness analysis of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Obstructive Sleep Apnea Other: Standard care Device: continuous positive airway pressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1864 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : April 2011
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Lifestyle
Standard care for OSA: lifestyle, and sleep hygiene counselling
Other: Standard care
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.

Experimental: Continuous positive airway pressure CPAP
CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling
Other: Standard care
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.

Device: continuous positive airway pressure
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.

No Intervention: Reference
This group will be followed according to cardiovascular protocols and will be evaluated as a reference group.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Prevalence of OSA in patients who have suffered an episode of ACS. [ Time Frame: 24 month (inclusion period) ]
    Determined at the inclusion of the patient

  2. Composite of major CV events [ Time Frame: 12 month after the inclusion of the last patient ]
    CV death, myocardial infarction (MI) and ischaemic stroke.

  3. Components of primary composite endpoints separately. [ 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.

  4. Number of re-vascularization procedures. [ Time Frame: 12 month after the inclusion of the last patient ]
    Revascularisation procedures, including PCI, CABG, peripheral arterial revascularisation and intra-cerebral stent insertion

  5. All-cause mortality. [ Time Frame: 12 month after the inclusion of the last patient ]
    All-cause mortality.

  6. New onset of ECG-confirmed atrial fibrillation or other arrhythmias. [ Time Frame: 12 month after the inclusion of the last patient ]
    ECGs were performed at baseline and during the follow-up period; ECG and medical records were collected tovconfirm a hospitalization for atrial fibrillation event

  7. Newly diagnosed diabetes mellitus, according to standard definitions. [ Time Frame: 12 month after the inclusion of the last patient ]
    Newly diagnosed diabetes mellitus, according to standard definitions

  8. Epworth Sleepiness Scale (ESS) and Test EuroQol (EQ-5D). [ Time Frame: 12 month after the inclusion of the last patient ]
    OSA symptoms: Epworth Sleepiness Scale (ESS). Quality of life: Test EuroQol (EQ-5D).

  9. Severity and phenotype of patients with OSA and clinical outcomes of ACS. [ Time Frame: 12 month after the inclusion of the last patient ]
    To establish the relationship between the severity and phenotype of patients with OSA and clinical outcomes of ACS.

  10. CPAP compliance and CV events incidence. [ Time Frame: 12 month after the inclusion of the last patient ]
    To establish the relationship between CPAP compliance and CV events incidence.

  11. Biological risk markers related to mechanisms involved in cardiovascular complications in these patients. [ Time Frame: 12 month after the inclusion of the last patient ]
    To identify biological risk markers that allow us to establish the most important mechanisms involved in cardiovascular complications in these patients.

  12. 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 ]
    Cost-effectiveness analysis (Qualys) of the diagnosis and CPAP treatment of patients with ACS who have obstructive sleep apnea



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women over 18 years old.
  2. 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 .
  3. Patients with and Epworth Sleep Scale score ≤ 10 (patients without excessive daytime sleepiness).
  4. Written informed consent signed.

Exclusion Criteria:

  1. Previous CPAP treatment for OSA diagnosis
  2. Psycho-physical inability to complete questionnaires.
  3. Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, regular use of hypnotic or sedative medications and restless leg syndrome
  4. Patients with > 50% of central apneas or the presence of Cheyne-Stokes Respiration (CSResp)
  5. Patients with chronic diseases: neoplasia, renal failure (GFR<30 ml/min), severe chronic obstructive pulmonary disease, chronic depression and other very limiting chronic diseases.
  6. A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
  7. 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).
  8. Any process, cardiovascular or otherwise, that limits life expectancy to less than one year.
  9. Patients in cardiogenic shock who have poor expectations for short-term outcomes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335087


Locations
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Spain
Spanish Respiratory Society
Barcelone, Spain, 08009
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
ResMed
Fondo de Investigacion Sanitaria
EsteveTeijin Healthcare
Societat Catalana de Cardiologia
Sociedad Madrileña de Neumologia
Investigators
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Principal Investigator: Ferran Barbe, MD Spanish Respiratory Sociey

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ferran Barbe, MD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01335087    
Other Study ID Numbers: PI10/02763
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Keywords provided by Ferran Barbe, Sociedad Española de Neumología y Cirugía Torácica:
sleep apnea
secondary prevention
cardiovascular endpoint
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases