Impact of the Obstructive Sleep Apnea Syndrome (OSAS) on the Ventricular Remodeling After Acute Myocardial Infarction

NCT ID: NCT02439294

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-13
• Study Completion Date: 2021-03-05

Brief Summary

Coronary artery disease is a common and serious disease, the leading cause of death worldwide. Obstructive sleep apnea syndrome (OSAS) is common and often under-diagnosed in coronary artery disease where it could be involved in the pathophysiology and perhaps prognosis. The entanglement of the two pathologies is actually quite well known, in particular the consequences of one over the other just beginning to be studied. Understanding the pathophysiology through new imaging modalities should improve the management of patients to propose new approaches.

"SAS-IDM" is an interventional and prospective study conducted at the University Hospital of Montpellier. Patients will be divided in three groups depending of the results of the polysomnography: 1/ AHI < 5/h: normal, without OSA ; 2/ 5/h ≤ AHI < 30/h: mild or moderate OSA ; 3/ IAH ≥ 30/h: severe OSA. A treatment by CPAP will be proposed to patients of the group "severe OSA".

Conditions

Recent Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Without Obstructive Sleep Apnea (syndrome)

Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups

Group Type: OTHER

Without Obstructive Sleep Apnea (syndrome)

Intervention Type: OTHER

Mild or moderate Obstructive Sleep Apnea (syndrome)

Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups

Group Type: OTHER

Mild or moderate Obstructive Sleep Apnea (syndrome)

Intervention Type: OTHER

Severe Obstructive Sleep Apnea (syndrome)

Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups

Group Type: OTHER

Severe Obstructive Sleep Apnea (syndrome)

Intervention Type: OTHER

CPAP

Intervention Type: DEVICE

Interventions

Without Obstructive Sleep Apnea (syndrome)

Intervention Type: OTHER

Mild or moderate Obstructive Sleep Apnea (syndrome)

Intervention Type: OTHER

Severe Obstructive Sleep Apnea (syndrome)

Intervention Type: OTHER

CPAP

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures,
• Adults, men and women aged < 90 years,
• Hospitalized in Intensive Care Units, MI confirmed by the study of the coronary arteries (coronary angiography) in acute phase (primary coronary angiography) or secondarily (ambulatory IDM IDM initially reperfused by thrombolysis),
• Myocardial infarction defined the criteria normally applied (STEMI: ST segment depression greater than 2 mm in at least 2 contiguous leads or new onset of pain and a left bundle branch block),
• The score of delayed enhancement MRI should be greater than 5 segments of 17 during the first MRI (criterion of severity of AMI),
• The subject must be affiliated to a social security scheme

Exclusion Criteria

• Patients for whom CPAP equipment has demonstrated its usefulness regardless of cardiovascular context

• Patients sleepy (Epworth score> 13)
• Road Truckers
• Contraindication to achieve cardiac MRI (primary endpoint):

• known and crippling claustrophobia,
• metal clips intracranial, intraocular,
• presence of an implantable defibrillator
• presence of a pacemaker
• history of injury by firearm or shrapnel balance without known projections
• hypersensitivity to gadolinium products (or history of systemic sclerosis skin) or severe renal impairment with creatinine clearance <30 ml / min
• any other known cause of contra-indication.
• Mild infarction (rate of late enhancement MRI in less than or equal to 4 segments of 17 during the first MRI)
• Patient previously treated with CPAP prior MI or already experienced with sleep apnea syndrome.
• SAS whose central part is predominantly (> 50%)
• General

• Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
• No affiliation to a French social security recipient or not such a scheme
• Major protected by law (guardianship, curators or under judicial protection)
• deprivation of liberty by judicial or administrative decision
• Increased likelihood of non compliance to the protocol or abandonment under study
• History or presence of psychoactive substance abuse
• pregnancy, become pregnant, or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, , France

Countries

France

Other Identifiers

9541

Identifier Type: -

Identifier Source: org_study_id