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

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ClinicalTrials.gov Identifier: NCT02439294
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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".


Condition or disease Intervention/treatment Phase
Recent Acute Myocardial Infarction Other: Without Obstructive Sleep Apnea (syndrome) Other: Mild or moderate Obstructive Sleep Apnea (syndrome) Other: Severe Obstructive Sleep Apnea (syndrome) Device: CPAP Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : May 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Without Obstructive Sleep Apnea (syndrome)
Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups
Other: Without Obstructive Sleep Apnea (syndrome)
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
Other: Mild or moderate Obstructive Sleep Apnea (syndrome)
Severe Obstructive Sleep Apnea (syndrome)
Subjects will be randomized after the results of the polysomnography (21st day ± 10) in one of this three groups
Other: Severe Obstructive Sleep Apnea (syndrome)
Device: CPAP



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 Measures :
  1. The difference in cardiac remodeling in cardiac MRI at 6 months between the three diagnostic categories [ Time Frame: At 6 months after inclusion ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02439294


Contacts
Contact: Kamila SOLECKI 0033 7 88 01 42 57 k-solecki@chu-montpellier.fr

Locations
France
Hôpital Arnaud de Villeneuve - CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Kamila SOLECKI    0033 7 88 01 42 57    k-solecki@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02439294     History of Changes
Other Study ID Numbers: 9541
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by University Hospital, Montpellier:
Recent acute myocardial infarction
Obstructive sleep apnée (syndrome)
Ventricular remodeling
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Sleep Apnea, Obstructive
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathological Conditions, Anatomical