- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05924503
BRAIN-HEART Ultrasound Study Normative Values for Transcranial Doppler Based Cerebral Blood Flow Assessment (MCS)
Cerebrovascular Investigation Relative to Systemic Circulatory Parameters Using Longitudinal Assessments on Transcranial Doppler to Evaluate Mechanical Circulatory Support [CIRCULATE-MCS]
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Aarti Sarwal, MD
- Phone Number: 336.716.2357
- Email: asarwal@wakehealth.edu
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Principal Investigator:
- Aarti Sarwal, MD
-
Contact:
- Aarti Sarwal, MD
- Phone Number: 336-716-2357
- Email: asarwal@wakehealth.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Transcranial Doppler
Serial daily TCD during the ICU stay involving bilateral Middle cerebral artery (MCA) insonation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Normative range of transcranial Doppler intracranial flow velocity - Baseline
Time Frame: 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
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Normative range of transcranial Doppler intracranial flow velocity- daily up to 2 years
Time Frame: 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
Time Frame: Baseline
|
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
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Baseline
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Normative range of transcranial Doppler-derived pulsatility index- daily up to 2 years
Time Frame: 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
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daily up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of neurological complications observed in patients enrolled in the study
Time Frame: Baseline and daily up to 2 years
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Number of neurological complications observed in patients enrolled in the study and the nature of complications described as type of neurological injury (delirium, ischemic stroke, hemorrhagic stroke, seizures, hypoxic ischemic brain injury, cognitive dysfunction unspecified).
This will descriptive parameter described in the enrolled population.
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Baseline and daily up to 2 years
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Association of abnormalities seen in cerebral blood flow assessed using transcranial Doppler-derived
Time Frame: Up to 2 years
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Association of abnormalities seen in cerebral blood flow assessed using transcranial Doppler-derived parameters (intracranial velocity of MCA, ACA, ICA, PCA, vertebral and basilar A in cm/s) adjusted to MCS systemic dynamics ( LV to blood flow 0-1000cm/s).
Comparison between groups of patients with and without neurological complications will be done using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables.
Regression analysis will be performed to identify independent outcome predictors of neurological complications.
Other inferential statistical analysis will be conducted as appropriate.
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Up to 2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Aarti Sarwal, MD, Wake Forest University Health Sciences
- Principal Investigator: Ashish Khanna, MD, Wake Forest University Health Sciences
- Principal Investigator: Connor O'Brien, University of California, San Francisco
- Principal Investigator: John Gaillard, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00094922
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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