Ignite Creation Date:
2024-05-05 @ 11:28 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01335087
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2011-04-05
Brief Title:
Continuous Positive Airway Pressure CPAP in Patients With Acute Coronary Syndrome and Obstructive Sleep Apnea OSA
Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Organization:
Sociedad Española de Neumología y Cirugía Torácica
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISAACC
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
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
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 1864 patients as follows patients with an AHI 15 h-1 will be randomized to CPAP treatment Group 1 n632 or conservative treatment Group 2 n632 Patients with an AHI 15 h-1 that will be followed as a reference group Group 3 n600
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 inew 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 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 1864 patients as follows patients with an AHI 15 h-1 will be randomized to CPAP treatment Group 1 n632 or conservative treatment Group 2 n632 Patients with an AHI 15 h-1 that will be followed as a reference group Group 3 n600
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 inew 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None