BRAIN-HEART Ultrasound Study Normative Values for Transcranial Doppler Based Cerebral Blood Flow Assessment

NCT05924503 | Terminated

• 1 other identifier: IRB00094922
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

There is a dire need to establish normative values for transcranial Doppler(TCD) derived cerebral blood flow parameters for each type of Mechanical circulatory support (MCS) device and explore the relationship between the MCS device's systemic flow dynamics and TCD based cerebral flow(CBF) parameters TCD derived cerebral blood flow parameters can then be investigated as targets used to titrate systemic flow dynamics from MCS. Having target flow rates titrated to patient specific condition using TCD may help avoid both hypoperfusion as well as the possibility of hyperemia reperfusion injury contributing to neurological morbidity. We propose a multicenter study to gather normative data on TCD derived CBF and MCS systemic dynamics for a wide range of patient demographics. Such data collection is only possible with multi-center collaboration given the small volume of patients with MCS patients in each center.

Conditions

Mechanical Circulatory Support

Keywords

hemodynamic support; Traditional neuroimaging methods; neurological complications

Outcome Measures

Primary Outcomes (4)

• Normative range of transcranial Doppler intracranial flow velocity - Baseline

  Normal mean velocity of the intracranial blood vessels (Middle cerebral artery (MCA), Internal carotid artery (ICA) Posterior Cerebral Arteries (PCA), Anterior Cerebral Artery (ACA), Basilar and Vertebral A )is usually \< 80 cm/s in patients with normal cardiac output. We will explore the range of normal values of intracranial vessel velocity in patients with different degree/ type of MCS devices adjusted to the contribution of LV to blood flow 0-10 L/min

  Baseline

• Normative range of transcranial Doppler intracranial flow velocity- daily up to 2 years

  Assess serial changes in intracranial vessel velocity ( MCA, ICA PCA, ACA, Basilar and Vertebral A ) that occur with changes in systemic dynamics related to change in MCS settings

  daily up to 2 years

• Normative range of transcranial Doppler-derived pulsatility index

  Normal pulsatility index for intracranial vessels index ( MCA, ICA PCA, ACA, Basilar and Vertebral A ) is 0.6-1.2 in patients with normal cardiac output. We will describe the correlation between transcranial Doppler-derived Pulsatility index and degree/ type of mechanical circulatory support and the contribution of LV to blood flow 0-10 L/min

  Baseline

• Normative range of transcranial Doppler-derived pulsatility index- daily up to 2 years

  Assess serial changes in transcranial Doppler-derived pulsatility index ( MCA, ICA PCA, ACA, Basilar and Vertebral A ) that occur with changes in systemic dynamics related to change in MCS settings

  daily up to 2 years

Secondary Outcomes (2)

• Number of neurological complications observed in patients enrolled in the study

  Baseline and daily up to 2 years

• Association of abnormalities seen in cerebral blood flow assessed using transcranial Doppler-derived

  Up to 2 years

Study Arms (1)

Transcranial Doppler

Serial daily TCD during the ICU stay involving bilateral Middle cerebral artery (MCA) insonation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the intensive care unit or inpatient wards for cardiogenic shock requiring mechanical circulatory support

You may qualify if:

• \>18 years old on the day of enrollment
• Mechanical circulatory support
• a. Left Ventricular Assist Device \[HeartMate-III\] in antegrade flow i. Critically ill ii. With and without pulsatility b. Impella antegrade flow c. VA-ECMO (VA-ECMO) is a temporary mechanical circulatory support system that enables complete and immediate cardiopulmonary support in the setting of cardiogenic shock and cardiac arrest) retrograde flow usual with femoral cannulation or antegrade flow if centrally cannulated
• Patient must be in the intensive care unit or in patient for the intervention to be performed

You may not qualify if:

• Known cerebrovascular disease or know angiographic abnormalities based on preexisting computed tomography angiography, digital subtraction angiography or transcranial Doppler prior to this hospitalization that will significantly affect Transcranial Doppler (TCD) parameters. Patients with abnormalities not likely to affect TCD parameters or known normal TCDs despite abnormal cerebral hemodynamic studies will still be included
• Pre-Existing neurological deficits impairing quality of life
• Absence of temporal windows
• Presence of skull defects that may affect the feasibility of TCD windows
• Co-existing dialysis or other forms of renal replacement therapy
• Pregnant patients
• Patients on palliative care pathway awaiting de-escalation
• Patient on comfort care

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Aarti Sarwal, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Connor O'Brien

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Ashish Khanna, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• John Gaillard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: June 29, 2023
• Study Start: May 22, 2024
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)