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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 20, 2023

Keywords

ClinConnect Summary

The BRAIN-HEART Ultrasound Study is a clinical trial that aims to gather important information about how blood flows in the brain of patients who are using mechanical devices to support heart function, like Left Ventricular Assist Devices and Impella. This study is essential because it will help establish normal blood flow values for these patients, which can lead to better management of their care. By understanding how these heart devices affect blood flow in the brain, doctors can adjust treatment to prevent problems like not enough blood flow (hypoperfusion) or too much blood flow (hyperemia), which can lead to brain injury.

To be eligible for this study, participants must be at least 18 years old and currently receiving mechanical circulatory support in a hospital, specifically in an intensive care unit. Key devices involved include the HeartMate-III and Impella, among others. Participants will undergo tests that measure blood flow in the brain using a technique called transcranial Doppler (TCD). This study is currently recruiting, and it is important for patients and families to know that their participation will help improve care for future patients with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \>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 Criteria:
• • 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