Establishing normal cerebral blood flow values for patients on mechanical heart support
Cerebrovascular Investigation Relative to Systemic Circulatory Parameters Using Longitudinal Assessments on Transcranial Doppler to Evaluate Mechanical Circulatory Support [CIRCULATE-MCS]
This study is trying to find out the normal blood flow levels in the brains of patients using mechanical heart support devices to help doctors manage their care better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05924503 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather normative data on transcranial Doppler (TCD) derived cerebral blood flow parameters in patients using various mechanical circulatory support (MCS) devices. By analyzing the relationship between systemic flow dynamics of MCS devices and TCD measurements, the study seeks to identify target flow rates tailored to individual patient conditions. This multicenter collaboration is essential due to the limited number of MCS patients at each center, allowing for a more comprehensive understanding of cerebral flow dynamics and potential neurological complications. The findings could lead to improved management of patients receiving MCS by optimizing flow rates to prevent hypoperfusion and hyperemia.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients over 18 years old who are receiving mechanical circulatory support, such as LVADs or VA-ECMO.
Not a fit: Patients with known cerebrovascular disease or significant angiographic abnormalities that could affect TCD parameters may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of mechanical circulatory support by providing tailored flow rate recommendations to prevent neurological complications.
How similar studies have performed: While previous studies have explored the effects of MCS devices on cerebral flow, this study is novel in its approach to establish normative values across multiple centers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Aarti Sarwal, MD — Wake Forest University Health Sciences
- Study coordinator: Aarti Sarwal, MD
- Email: asarwal@wakehealth.edu
- Phone: 336.716.2357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.