RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-22
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05924503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>18 years old on the day of enrollment
  2. * Mechanical circulatory support
  3. * Patient must be in the intensive care unit or in patient for the intervention to be performed
  1. * 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
  2. * Pre-Existing neurological deficits impairing quality of life
  3. * Absence of temporal windows
  4. * Presence of skull defects that may affect the feasibility of TCD windows
  5. * Co-existing dialysis or other forms of renal replacement therapy
  6. * Pregnant patients
  7. * Patients on palliative care pathway awaiting de-escalation
  8. * Patient on comfort care

Contacts and Locations

Study Contact

Aarti Sarwal, MD
CONTACT
336.716.2357
asarwal@wakehealth.edu

Principal Investigator

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
John Gaillard, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • 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
  • John Gaillard, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-22
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-05-22
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • hemodynamic support
  • Traditional neuroimaging methods
  • neurological complications

Additional Relevant MeSH Terms

  • Mechanical Circulatory Support