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

Primary Purpose

Recent Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Without Obstructive Sleep Apnea (syndrome)
Mild or moderate Obstructive Sleep Apnea (syndrome)
Severe Obstructive Sleep Apnea (syndrome)
CPAP
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Recent Acute Myocardial Infarction focused on measuring Recent acute myocardial infarction, Obstructive sleep apnée (syndrome), Ventricular remodeling, Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Arnaud de Villeneuve - CHU de Montpellier

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Without Obstructive Sleep Apnea (syndrome)

Mild or moderate Obstructive Sleep Apnea (syndrome)

Severe Obstructive Sleep Apnea (syndrome)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Changes in diameter (mm) and end diastolic and systolic LV volumes (mL) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Transmural enhancement (%) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Thickness of the LV wall (mm) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Presence no reflow at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)

Secondary Outcome Measures

The difference in cardiac remodeling in cardiac MRI at 6 months between the three diagnostic categories
The difference in cardiac remodeling in cardiac MRI between the date of inclusion and 6 months between diagnostic categories.
The difference of left ventricular remodeling in cardiac MRI between the date of inclusion and 6 months in the severe OSA group based on the assumption (good compliance and effectiveness of PPC or not)
The occurrence of cardiovascular events during the first year following the IDM depending on the initial AHI index.

Full Information

First Posted
April 28, 2015
Last Updated
July 7, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02439294
Brief Title
Impact of the Obstructive Sleep Apnea Syndrome (OSAS) on the Ventricular Remodeling After Acute Myocardial Infarction
Acronym
SAS-IDM
Official Title
Impact of the Obstructive Sleep Apnea Syndrome (OSAS) on the Ventricular Remodeling After Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 13, 2015 (Actual)
Primary Completion Date
March 5, 2021 (Actual)
Study Completion Date
March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recent Acute Myocardial Infarction
Keywords
Recent acute myocardial infarction, Obstructive sleep apnée (syndrome), Ventricular remodeling, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Without Obstructive Sleep Apnea (syndrome)
Arm Type
Other
Arm Description
Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups
Arm Title
Mild or moderate Obstructive Sleep Apnea (syndrome)
Arm Type
Other
Arm Description
Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups
Arm Title
Severe Obstructive Sleep Apnea (syndrome)
Arm Type
Other
Arm Description
Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups
Intervention Type
Other
Intervention Name(s)
Without Obstructive Sleep Apnea (syndrome)
Intervention Type
Other
Intervention Name(s)
Mild or moderate Obstructive Sleep Apnea (syndrome)
Intervention Type
Other
Intervention Name(s)
Severe Obstructive Sleep Apnea (syndrome)
Intervention Type
Device
Intervention Name(s)
CPAP
Primary Outcome Measure Information:
Title
Changes in diameter (mm) and end diastolic and systolic LV volumes (mL) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Time Frame
6 months of acute MI
Title
Transmural enhancement (%) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Time Frame
6 months of acute MI
Title
Thickness of the LV wall (mm) at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Time Frame
6 months of acute MI
Title
Presence no reflow at 6 months of acute MI among a group of patients without OSA (AHI <5 / h) and a group of patients with mild to moderate OSA (AHI between 5 and 30 / h)
Time Frame
6 months of acute MI
Secondary Outcome Measure Information:
Title
The difference in cardiac remodeling in cardiac MRI at 6 months between the three diagnostic categories
Time Frame
At 6 months after inclusion
Title
The difference in cardiac remodeling in cardiac MRI between the date of inclusion and 6 months between diagnostic categories.
Time Frame
Between the date of inclusion and 6 months
Title
The difference of left ventricular remodeling in cardiac MRI between the date of inclusion and 6 months in the severe OSA group based on the assumption (good compliance and effectiveness of PPC or not)
Time Frame
Between the date of inclusion and 6 months
Title
The occurrence of cardiovascular events during the first year following the IDM depending on the initial AHI index.
Time Frame
Between the date of inclusion and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hôpital Arnaud de Villeneuve - CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

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

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