search
Back to results

Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography (Echo-TC)

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transthoracic echocardiography on TBI patients
Transthoracic echocardiography on control patients
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring Traumatic brain injury, Myocardial dysfunction, Transthoracic echocardiography, Speckle tracking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

TBI patients

Inclusion Criteria:

  • Isolated and non opened traumatic brain injury
  • 18 - 65 years old
  • Intubated and mechanically ventilated
  • Glasgow score < or = 9 or
  • Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries
  • Medical insurance

Exclusion Criteria:

  • Treated major cardiovascular risks factors
  • cardiovascular past medical history (acute cardiovascular event)
  • Cardio thoracic surgery
  • Brain dead status
  • Inotrope drugs
  • Severe polytraumatism
  • Acute haemorrhage
  • Non echogenic patient
  • High level athlete
  • Incapacitated person by law and pregnant women
  • Discovery during echocardiography of underlying cardiomyopathy
  • Urgent neurosurgery required

Control patients

Inclusion Criteria:

  • Isolated and non opened traumatic brain injury
  • 18 - 65 years old
  • Intubated and mechanically ventilated
  • Paired with TBI patient on age, BMI and sex
  • Undergoing urgent non severe surgery
  • Medical insurance

Exclusion Criteria:

  • Traumatic brain injury
  • Treated major cardiovascular risks factors
  • cardiovascular past medical history (acute cardiovascular event)
  • Cardio thoracic surgery
  • Inotrope and vasopressive drugs
  • Circulatory failure
  • Non echogenic patient
  • High level athlete
  • Incapacitated person by law and pregnant women
  • Discovery during echocardiography of underlying cardiomyopathy
  • Urgent neurosurgery required

Sites / Locations

  • University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Traumatic brain injury

Controls

Arm Description

Two dimensional and speckle tracking transthoracic echocardiography in traumatic brain injured patients Glasgow score < or = 9 or Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages: diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries

Two dimensional and speckle tracking transthoracic echocardiography in control patients paired with traumatic brain injured patient on age, BMI and sex with the following criteria: Intubated and mechanically ventilated Undergoing urgent non severe surgery

Outcomes

Primary Outcome Measures

left ventricular ejection fraction

Secondary Outcome Measures

Strain evaluation by speckle tracking (in percentage of systolic duration)
Systolic strain rate by speckle tracking (in second)
Diastolic strain rate by speckle tracking (in second)
Systolic rotational velocity by speckle tracking (in degree by second)
Diastolic rotational velocity by speckle tracking (in degree by second)
Systolic twisting velocity by speckle tracking (in degree by second)
Diastolic untwisting velocity by speckle tracking (in degree by second)
Myocardial wall thickness (in millimeter)
2D transthoracic echography
left ventricular diastolic function (cm/sec)
2D transthoracic echography
Cardiac index
2D transthoracic echography
tissue doppler imaging (cm/sec)
2D transthoracic echography
right ventricular diastolic function
2D transthoracic echography
right ventricular systolic function
2D transthoracic echography

Full Information

First Posted
February 23, 2015
Last Updated
December 8, 2015
Sponsor
University Hospital, Grenoble
search

1. Study Identification

Unique Protocol Identification Number
NCT02380482
Brief Title
Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography
Acronym
Echo-TC
Official Title
Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial dysfunction might occur at the early phase of the traumatic brain injury. This myocardial dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case, improving myocardial dysfunction may help to increase cerebral blood flow and improve patient prognosis. In clinical practice the easiest and non invasive way to explore myocardial dysfunction is with transthoracic echocardiography. The objective of this trial is to investigate myocardial dysfunction at the early phase of traumatic brain injury, compared with a controlled group without TBI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic brain injury, Myocardial dysfunction, Transthoracic echocardiography, Speckle tracking

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traumatic brain injury
Arm Type
Other
Arm Description
Two dimensional and speckle tracking transthoracic echocardiography in traumatic brain injured patients Glasgow score < or = 9 or Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages: diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries
Arm Title
Controls
Arm Type
Other
Arm Description
Two dimensional and speckle tracking transthoracic echocardiography in control patients paired with traumatic brain injured patient on age, BMI and sex with the following criteria: Intubated and mechanically ventilated Undergoing urgent non severe surgery
Intervention Type
Other
Intervention Name(s)
Transthoracic echocardiography on TBI patients
Intervention Description
Two Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma
Intervention Type
Other
Intervention Name(s)
Transthoracic echocardiography on control patients
Intervention Description
Two Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated
Primary Outcome Measure Information:
Title
left ventricular ejection fraction
Time Frame
within the first 24 hours after injury
Secondary Outcome Measure Information:
Title
Strain evaluation by speckle tracking (in percentage of systolic duration)
Time Frame
within the first 24 hours after injury
Title
Systolic strain rate by speckle tracking (in second)
Time Frame
within the first 24 hours after injury
Title
Diastolic strain rate by speckle tracking (in second)
Time Frame
within the first 24 hours after injury
Title
Systolic rotational velocity by speckle tracking (in degree by second)
Time Frame
within the first 24 hours after injury
Title
Diastolic rotational velocity by speckle tracking (in degree by second)
Time Frame
within the first 24 hours after injury
Title
Systolic twisting velocity by speckle tracking (in degree by second)
Time Frame
within the first 24 hours after injury
Title
Diastolic untwisting velocity by speckle tracking (in degree by second)
Time Frame
within the first 24 hours after injury
Title
Myocardial wall thickness (in millimeter)
Description
2D transthoracic echography
Time Frame
within the first 24 hours after injury
Title
left ventricular diastolic function (cm/sec)
Description
2D transthoracic echography
Time Frame
within the first 24 hours after injury
Title
Cardiac index
Description
2D transthoracic echography
Time Frame
within the first 24 hours after injury
Title
tissue doppler imaging (cm/sec)
Description
2D transthoracic echography
Time Frame
within the first 24 hours after injury
Title
right ventricular diastolic function
Description
2D transthoracic echography
Time Frame
within the first 24 hours after injury
Title
right ventricular systolic function
Description
2D transthoracic echography
Time Frame
within the first 24 hours after injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
TBI patients Inclusion Criteria: Isolated and non opened traumatic brain injury 18 - 65 years old Intubated and mechanically ventilated Glasgow score < or = 9 or Glasgow score between 9 and 13 (included) and Following Traumatic Coma Data Bank Tomographic Damages diffuse injuries type III or IV or mass lesion over 25ml and/or neurosurgical injuries Medical insurance Exclusion Criteria: Treated major cardiovascular risks factors cardiovascular past medical history (acute cardiovascular event) Cardio thoracic surgery Brain dead status Inotrope drugs Severe polytraumatism Acute haemorrhage Non echogenic patient High level athlete Incapacitated person by law and pregnant women Discovery during echocardiography of underlying cardiomyopathy Urgent neurosurgery required Control patients Inclusion Criteria: Isolated and non opened traumatic brain injury 18 - 65 years old Intubated and mechanically ventilated Paired with TBI patient on age, BMI and sex Undergoing urgent non severe surgery Medical insurance Exclusion Criteria: Traumatic brain injury Treated major cardiovascular risks factors cardiovascular past medical history (acute cardiovascular event) Cardio thoracic surgery Inotrope and vasopressive drugs Circulatory failure Non echogenic patient High level athlete Incapacitated person by law and pregnant women Discovery during echocardiography of underlying cardiomyopathy Urgent neurosurgery required
Facility Information:
Facility Name
University hospital
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16926367
Citation
Bahloul M, Chaari AN, Kallel H, Khabir A, Ayadi A, Charfeddine H, Hergafi L, Chaari AD, Chelly HE, Ben Hamida C, Rekik N, Bouaziz M. Neurogenic pulmonary edema due to traumatic brain injury: evidence of cardiac dysfunction. Am J Crit Care. 2006 Sep;15(5):462-70.
Results Reference
background
PubMed Identifier
11823097
Citation
Eagle KA, Berger PB, Calkins H, Chaitman BR, Ewy GA, Fleischmann KE, Fleisher LA, Froehlich JB, Gusberg RJ, Leppo JA, Ryan T, Schlant RC, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Jacobs AK, Hiratzka LF, Russell RO, Smith SC Jr; American College of Cardiology; American Heart Association. ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery). J Am Coll Cardiol. 2002 Feb 6;39(3):542-53. doi: 10.1016/s0735-1097(01)01788-0. No abstract available. Erratum In: J Am Coll Cardiol. 2006 Jun 6;47(11):2356.
Results Reference
background
PubMed Identifier
16376782
Citation
Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.
Results Reference
background
PubMed Identifier
21338865
Citation
Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. J Am Soc Echocardiogr. 2011 Mar;24(3):277-313. doi: 10.1016/j.echo.2011.01.015.
Results Reference
background
PubMed Identifier
22311230
Citation
Moussouttas M, Lai EW, Khoury J, Huynh TT, Dombrowski K, Pacak K. Determinants of central sympathetic activation in spontaneous primary subarachnoid hemorrhage. Neurocrit Care. 2012 Jun;16(3):381-8. doi: 10.1007/s12028-012-9673-5.
Results Reference
background
PubMed Identifier
23963125
Citation
Prathep S, Sharma D, Hallman M, Joffe A, Krishnamoorthy V, Mackensen GB, Vavilala MS. Preliminary report on cardiac dysfunction after isolated traumatic brain injury. Crit Care Med. 2014 Jan;42(1):142-7. doi: 10.1097/CCM.0b013e318298a890.
Results Reference
background
PubMed Identifier
18496376
Citation
Rosenthal G, Hemphill JC 3rd, Sorani M, Martin C, Morabito D, Obrist WD, Manley GT. Brain tissue oxygen tension is more indicative of oxygen diffusion than oxygen delivery and metabolism in patients with traumatic brain injury. Crit Care Med. 2008 Jun;36(6):1917-24. doi: 10.1097/CCM.0b013e3181743d77.
Results Reference
background
PubMed Identifier
4061050
Citation
Schrader H, Hall C, Zwetnow NN. Effects of prolonged supratentorial mass expansion on regional blood flow and cardiovascular parameters during the Cushing response. Acta Neurol Scand. 1985 Sep;72(3):283-94. doi: 10.1111/j.1600-0404.1985.tb00872.x.
Results Reference
background
PubMed Identifier
3403832
Citation
Shanlin RJ, Sole MJ, Rahimifar M, Tator CH, Factor SM. Increased intracranial pressure elicits hypertension, increased sympathetic activity, electrocardiographic abnormalities and myocardial damage in rats. J Am Coll Cardiol. 1988 Sep;12(3):727-36. doi: 10.1016/s0735-1097(88)80065-2.
Results Reference
background
PubMed Identifier
8419012
Citation
Shivalkar B, Van Loon J, Wieland W, Tjandra-Maga TB, Borgers M, Plets C, Flameng W. Variable effects of explosive or gradual increase of intracranial pressure on myocardial structure and function. Circulation. 1993 Jan;87(1):230-9. doi: 10.1161/01.cir.87.1.230.
Results Reference
background
PubMed Identifier
19513307
Citation
Song HS, Back JH, Jin DK, Chung PW, Moon HS, Suh BC, Kim YB, Kim BM, Woo HY, Lee YT, Park KY. Cardiac troponin T elevation after stroke: relationships between elevated serum troponin T, stroke location, and prognosis. J Clin Neurol. 2008 Jun;4(2):75-83. doi: 10.3988/jcn.2008.4.2.75. Epub 2008 Jun 20.
Results Reference
background
PubMed Identifier
7769773
Citation
Sosin DM, Sniezek JE, Waxweiler RJ. Trends in death associated with traumatic brain injury, 1979 through 1992. Success and failure. JAMA. 1995 Jun 14;273(22):1778-80.
Results Reference
background
PubMed Identifier
27793208
Citation
Cuisinier A, Maufrais C, Payen JF, Nottin S, Walther G, Bouzat P. Myocardial function at the early phase of traumatic brain injury: a prospective controlled study. Scand J Trauma Resusc Emerg Med. 2016 Oct 28;24(1):129. doi: 10.1186/s13049-016-0323-3.
Results Reference
derived

Learn more about this trial

Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography

We'll reach out to this number within 24 hrs