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Trial record 4 of 195 for:    Hemorrhage AND SAH

Detection of Myocardial Dysfunction in Non-severe Subarachnoid Hemorrhage (WFNS 1-2) Using Speckle-tracking Echocardiography (STRAIN) (SAH-STRAIN)

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ClinicalTrials.gov Identifier: NCT03761654
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Subarachnoid hemorrhage (SAH) can cause transient myocardial dysfunction. Recently, it have been reported that myocardial dysfunctions that occur in SAH are associated with poor outcomes. It therefore appears essential to detect theses dysfunctions with the higher sensitivity as possible. Strain measurement using speckle-tracking echocardiography may detect myocardial dysfunction with great sensitivity. The main objective of this study is to assess the prevalence of myocardial dysfunction in "non-severe" SAH (defined by a WFNS grade 1 or 2), using speckle-tracking echocardiography. This study also aims to analyse Strain measurement with classical echocardiography and serum markers (troponin, BNP) of cardiac dysfunction.

Condition or disease Intervention/treatment
Subarachnoid Hemorrhage (SAH) Left Ventricular Dysfunction Stress Cardiomyopathy Diagnostic Test: Global Longitudinal Strain measure

Detailed Description:

Cardiac complication, occurring in the early phase of SAH has been well described. It seems that the pathophysiological mechanism involves vegetative hyperactivity due to the acute cerebral injury. It has been shown that stress cardiomyopathy is associated with delayed cerebral ischemia (DCI) and poor outcomes. Manifestations of stress cardiomyopathy are changes in electrocardiogram, release of cardiac biomarkers such as troponin and BNP, and echography evidence of impaired left ventricle ejection fraction with the use of Simpson technique and regional wall motion abnormalities. These two techniques bear intra-observer variability. A new method is available to assess left ventricular contractility at the bedside. Two-dimensional speckle-tracking images with echocardiography allows one to track a natural myocardial marker within the myocardium by standard transthoracic echocardiography. It provides unique insights into myocardial function such as tissue deformations and strain rate, which is the rate of deformation. This method is more sensitive than classical echographic left ventricular ejection fraction evaluation and bears very low interobserver variability. The Global Longitudinal Strain (GLS) is the most studied parameter.

Early detection of cardiac dysfunction in SAH followed by appropriate monitoring and management may improve outcome in SAH. This is a prospective, observational and mono-center study.

Patients with "non-severe" SAH will benefit from an echocardiography where Left Ventricular Ejection Fraction (LVEF) and GLS will be assessed on day 1, 3 and 7 following the acute injury.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Detection of Myocardial Dysfunction in Non-severe Subarachnoid Hemorrhage (WFNS 1-2) Using Speckle-tracking Echocardiography (STRAIN)
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
Patients with a "non-severe" subarachnoid hemorrhage Diagnostic Test: Global Longitudinal Strain measure
Global Longitudinal Strain measure on day 1 of hospitalization




Primary Outcome Measures :
  1. Global Longitudinal Strain [ Time Frame: Day 1 of hospitalization ]
    It is calculated using values of longitudinal strain measured in the three-,four-, and two-chamber of the left ventricle of the heart. GLS is expressed as percentage. Strain is a measure of myocardial muscle fiber shortening during contraction and is calculated as the systolic segment shortening between end-systolic (ES) segment length (L) and end-diastolic (ED) length: strain = (-LES - LED)/LED x 100 %.


Secondary Outcome Measures :
  1. Global Longitudinal Strain [ Time Frame: Day 3 of hospitalization ]
    is calculated using values of longitudinal strain measured in the three-,four-, and two-chamber of the left ventricle of the heart. GLS is expressed as percentage. Strain is a measure of myocardial muscle fiber shortening during contraction and is calculated as the systolic segment shortening between end-systolic (ES) segment length (L) and end-diastolic (ED) length: strain = (-LES - LED)/LED x 100 %.

  2. Global Longitudinal Strain [ Time Frame: Day 7 of hospitalization ]
    is calculated using values of longitudinal strain measured in the three-,four-, and two-chamber of the left ventricle of the heart. GLS is expressed as percentage. Strain is a measure of myocardial muscle fiber shortening during contraction and is calculated as the systolic segment shortening between end-systolic (ES) segment length (L) and end-diastolic (ED) length: strain = (-LES - LED)/LED x 100 %.

  3. Change of Left Ventricular Ejection Fraction using Simpson technique [ Time Frame: Days 1, 3 and 7 of hospitalization ]
  4. Change in serum troponin level [ Time Frame: Days 1, 3 and 7 of hospitalization ]
  5. Change in brain natriuretic peptide (BNP) level [ Time Frame: Days 1, 3 and 7 of hospitalization ]
  6. Electrocardiogram abnormalities [ Time Frame: Up to day 7 of hospitalization ]

    Abnormalities expected:

    • abnormal Q or QS wave (≥30 ms or a pathological R wave in V1 to V2)
    • ST de- pression (ST depression ≥ 0.1 mV, 80 ms post-J point)
    • ST elevation (ST elevation ≥ .1 mV)
    • peaked upright T wave (prominent peaked T wave)
    • T-wave inver- sion (pathologic T-wave inversion)
    • nonspecific ST- or T-wave changes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient older than 18 years hospitalized in neuro-intensive care unit with a "non-severe" subarachnoid hemorrhage (WFNS 1 or 2)
Criteria

Inclusion Criteria:

  • patient older than 18 years
  • hospitalized in neuro-intensive care unit with a "non-severe" subarachnoid hemorrhage (WFNS 1 or 2)

Exclusion Criteria:

  • low echogenicity
  • history of cardiac malformation or cardiac surgery
  • severe valvular heart disease
  • dilated cardiomyopathy
  • acute coronary syndrome
  • permanent arrythmia
  • patient refusal

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): NCT03761654


Contacts
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Contact: Matthieu BIAIS, MD-PhD 05 57 82 10 19 ext +33 matthieu.biais@chu-bordeaux.fr
Contact: Olivier BRANCHARD 05 57 82 06 97 ext +33 olivier.branchard@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Matthieu BIAIS, MD-PhD    05 57 82 10 19 ext +33    matthieu.biais@chu-bordeaux.fr   
Contact: Olivier BRANCHARD    05 57 82 06 97 ext +33    olivier.branchard@chu-bordeaux.fr   
Principal Investigator: Matthieu BIAIS, MD-PhD         
Sub-Investigator: Philippe BOYER, MD         
Sub-Investigator: Hugues DE COURSON, MD         
Sub-Investigator: Lisa LE GALL, MD         
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03761654     History of Changes
Other Study ID Numbers: CHUBX 2018/51
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Subarachnoid Hemorrhage (SAH)
Left Ventricular Dysfunction
Intensive Care Unit
Speckle-tracking
STRAIN
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Cardiomyopathies
Ventricular Dysfunction
Ventricular Dysfunction, Left
Takotsubo Cardiomyopathy
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases