Mechanical Circulatory SupportMCSNCT05924503
BRAIN-HEART Ultrasound Study Normative Values for Transcranial Doppler Based Cerebral Blood Flow Assessment
An observational study of Mechanical Circulatory Support, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Circulatory Support
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to 22 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the intensive care unit or inpatient wards for cardiogenic shock requiring mechanical circulatory support
Who may be able to join
- >18 years old on the day of enrollment
- Mechanical circulatory support
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Cerebrovascular Investigation Relative to Systemic Circulatory Parameters Using Longitudinal Assessments on Transcranial Doppler to Evaluate Mechanical Circulatory Support [CIRCULATE-MCS]
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.
Read the detailed description
The Mechanical circulatory support (MCS) devices are temporary devices that enable complete and immediate cardiopulmonary support in settings of cardiac arrest and cardiogenic shock. The different MCS devices differ in their operating principles and generate different systemic flow patterns (pulsatile vs non- pulsatile, flow volumes, Peak flow rates, and PI). Researchers have studied different MCS devices like VA Extra Corporeal Mebrane Oxygenation(ECMO), left ventricular assist device (LVAD), and Impella and their effect on cerebral flow and complication profiles using various neuromonitoring techniques including TCD . Most such studies were small single-center studies that added to the understanding of different flow rates and characteristics with different MCS devices but were not adequately powered or designed to establish normative values of TCD derived CBF measures in this special population. There is a dire need to establish normative values for each type of MCS device and explore the relationship between the MCS device's systemic flow dynamics and TCD derived cerebral flow. These normative values then can be used to assess the association of TCD derived CBF patterns with occurrence of neurological complications related to abnormal CBF in patients receiving MCS devices and advice on patient specific MCS parameters titrated using TCD derived parameters. Having target flow rates in MCS patients will help avoid both hypoperfusion as well as the possibility of hyperemia reperfusion injury contributing to neurological morbidity. 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Doppler | Serial daily TCD during the ICU stay involving bilateral Middle cerebral artery (MCA) insonation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: daily up to 2 years
Secondary outcomes (2)
Number of neurological complications observed in patients enrolled in the study
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.
Measured: Baseline and daily up to 2 years
Association of abnormalities seen in cerebral blood flow assessed using transcranial Doppler-derived
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start22 May 2024
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Why it stopped: investigator changed institutions-in process of transferring study to VCU
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Circulatory SupportStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Aarti Sarwal, MD, Principal investigator, Wake Forest University Health SciencesConnor O'Brien, Principal investigator, University of California, San FranciscoAshish Khanna, MD, Principal investigator, Wake Forest University Health SciencesJohn Gaillard, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924503
- Sponsor's protocol ID
- IRB00094922
- Acronym
- MCS
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2023
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Investigation Relative to Systemic Circulatory Parameters Using Longitudinal Assessments on Transcranial Doppler to Evaluate Mechanical Circulatory Support [CIRCULATE-MCS]
- ClinicalTrials.gov ID
- NCT05924503
- Acronym / sponsor ID
- MCS / IRB00094922
- Conditions
- Mechanical Circulatory Support
- Keywords
- hemodynamic support, Traditional neuroimaging methods, neurological complications
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: investigator changed institutions-in process of transferring study to VCU
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 22 May 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Mechanical circulatory support (MCS) devices are temporary devices that enable complete and immediate cardiopulmonary support in settings of cardiac arrest and cardiogenic shock. The different MCS devices differ in their operating principles and generate different systemic flow patterns (pulsatile vs non- pulsatile, flow volumes, Peak flow rates, and PI). Researchers have studied different MCS devices like VA Extra Corporeal Mebrane Oxygenation(ECMO), left ventricular assist device (LVAD), and Impella and their effect on cerebral flow and complication profiles using various neuromonitoring techniques including TCD . Most such studies were small single-center studies that added to the understanding of different flow rates and characteristics with different MCS devices but were not adequately powered or designed to establish normative values of TCD derived CBF measures in this special population. There is a dire need to establish normative values for each type of MCS device and explore the relationship between the MCS device's systemic flow dynamics and TCD derived cerebral flow. These normative values then can be used to assess the association of TCD derived CBF patterns with occurrence of neurological complications related to abnormal CBF in patients receiving MCS devices and advice on patient specific MCS parameters titrated using TCD derived parameters. Having target flow rates in MCS patients will help avoid both hypoperfusion as well as the possibility of hyperemia reperfusion injury contributing to neurological morbidity. Such data collection is only possible with multi-center collaboration given the small volume of patients with MCS patients in each center.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Doppler | – | –Serial daily TCD during the ICU stay involving bilateral Middle cerebral artery (MCA) insonation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit or inpatient wards for cardiogenic shock requiring mechanical circulatory support
Key inclusion criteria (4 listed)
- >18 years old on the day of enrollment
- Mechanical circulatory support
- Patient must be in the intensive care unit or in patient for the intervention to be performed
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
2 secondary outcomes
Number of neurological complications observed in patients enrolled in the study
Time frame: Baseline and daily up to 2 years
Association of abnormalities seen in cerebral blood flow assessed using transcranial Doppler-derived
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: investigator changed institutions-in process of transferring study to VCU). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Mechanical Circulatory Support
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Recruiting
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
Congenital Heart Disease
RecruitingObservational study
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
Cardiogenic Shock, Euthyroid Sick Syndrome
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aarti Sarwal, MD principal investigator
Wake Forest University Health Sciences
Connor O'Brien principal investigator
University of California, San Francisco
Ashish Khanna, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Circulatory Support, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: investigator changed institutions-in process of transferring study to VCU). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative range of transcranial Doppler intracranial flow velocity - Baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.