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Completed

NCT Number: NCT02439294

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

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".

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Key information

Conditions

Recent Acute Myocardial Infarction Disease Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Syndrome Ventricular Remodeling

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Without Obstructive Sleep Apnea (syndrome)

Other

Mild or moderate Obstructive Sleep Apnea (syndrome)

Other

Severe Obstructive Sleep Apnea (syndrome)

Other

CPAP

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: SAS-IDM

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
May 8, 2015
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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