NCT03761654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

November 29, 2018

Last Update Submit

January 5, 2021

Conditions

Keywords

Subarachnoid Hemorrhage (SAH)Left Ventricular DysfunctionIntensive Care UnitSpeckle-trackingSTRAIN

Outcome Measures

Primary Outcomes (1)

  • Global Longitudinal Strain

    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 %.

    Day 1 of hospitalization

Secondary Outcomes (6)

  • Global Longitudinal Strain

    Day 3 of hospitalization

  • Global Longitudinal Strain

    Day 7 of hospitalization

  • Change of Left Ventricular Ejection Fraction using Simpson technique

    Days 1, 3 and 7 of hospitalization

  • Change in serum troponin level

    Days 1, 3 and 7 of hospitalization

  • Change in brain natriuretic peptide (BNP) level

    Days 1, 3 and 7 of hospitalization

  • +1 more secondary outcomes

Study Arms (1)

Patients with a "non-severe" subarachnoid hemorrhage

Diagnostic Test: Global Longitudinal Strain measure

Interventions

Global Longitudinal Strain measure on day 1 of hospitalization

Patients with a "non-severe" subarachnoid hemorrhage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Subarachnoid HemorrhageVentricular Dysfunction, LeftTakotsubo CardiomyopathySprains and Strains

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsVentricular DysfunctionHeart DiseasesCardiomyopathiesWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 3, 2018

Study Start

January 2, 2019

Primary Completion

December 25, 2020

Study Completion

January 1, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations