RecruitingNCT05924503

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

Cerebrovascular Investigation Relative to Systemic Circulatory Parameters Using Longitudinal Assessments on Transcranial Doppler to Evaluate Mechanical Circulatory Support [CIRCULATE-MCS]

Sponsor

Wake Forest University Health Sciences

Enrollment

1,000 participants

Start Date

May 22, 2024

Study Type

OBSERVATIONAL

Conditions

Mechanical Circulatory Support

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

>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

Exclusion Criteria8

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