跳至主要内容
临床试验/NCT05924503
NCT05924503招募中不适用

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

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Normative range of transcranial Doppler-derived pulsatility index- daily up to 2 years

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >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

排除标准

  • 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

结局指标

主要结局

Normative range of transcranial Doppler-derived pulsatility index- daily up to 2 years

时间窗: 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

Normative range of transcranial Doppler intracranial flow velocity - Baseline

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

  • Number of neurological complications observed in patients enrolled in the study(Baseline and daily up to 2 years)
  • Association of abnormalities seen in cerebral blood flow assessed using transcranial Doppler-derived(Up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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