跳至主要内容
临床试验/NCT05250349
NCT05250349招募中不适用

TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence/Absence of Atherosclerotic Carotid Artery Stenosis

John Paul II Hospital, Krakow1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年9月1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
300
试验地点
1
主要终点
Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MMSE)

研究概览

简要总结

TRACE-IMPAIR is a prospective, clinical study of consecutive patients that evaluates the relationship between heart failure (HF) and cognitive impairment in relation to carotid and cerebral flow. The carotid and cerebral flow will be assessed using Doppler ultrasonography, and cognitive function will be estimated during routine neuropsychological tests.

It is an observational, three(natural)-group, single-center study. It is also an Academic Registry - the scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University, and John Paul II Hospital.

详细描述

Circumstantial evidence suggests that cognitive dysfunction may occur in HF patients as often undiagnosed comorbidity. Cognitive dysfunction may aggravate HF symptoms and influence prognosis. Cognitive dysfunction may be a reason for inadequate self-care and poor symptom control (e.g., weight gain monitoring). In addition, it may affect medication compliance, leading to hospital readmissions and increased mortality. Brain tissue hypoxia, microemboli, silent strokes, and co-existing anemia have been implicated in contributing to cognitive dysfunction in HF. However, the role of cerebral flow impairment in these patients remains unclear. This uncertainty is mainly because previous studies included small patient groups, diverse imaging techniques, and neuropsychological tests. Furthermore, these studies were primarily conducted in the elderly, a potentially important confounder due to the effect of age on cognitive dysfunction. Particularly little data is available for younger patients (< 60 years).

This study aims to investigate the association of HF, carotid and cerebral flow, and cognitive impairment. Consecutive patients with HF with mildly reduced (HFmrEF) and reduced ejection fraction (HFrEF) will be included in the study. Echocardiography with routine measurements such as ejection fraction and stroke volume will be performed in each patient. The carotid and cerebral flow will be assessed on Doppler ultrasonography. Each patient will undergo cognitive function assessment using Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). The results in the index group (isolated HF) will be compared with those in a group of patients with HF and flow-limiting carotid stenosis (CS) against a control group (no HF, no CS).

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Clinically stable patients (NYHA I-III symptoms) with HF (for at least 6 months) either of ischemic or inflammatory etiology as well as genetic cardiomyopathies
  • Signed informed consent form
  • Consent to imaging studies: echocardiography, carotid and transcranial Doppler sonography and neuropsychological tests (MMSE and MoCA).

排除标准

  • Co-existing, severe, irreversible disease (e.g. advanced cancer)
  • Previously diagnosed dementia (including severe dementia - MMSE and MoCA score <10)
  • Psychiatric condition which may influence cognitive function
  • Acute, decompensated HF
  • Reversible cause of HF - tachyarrhytmic, peripartum or toxic cardiomyopathy, acute myocarditis, acute myocardial infarction
  • Aortic stenosis
  • Cerebral stroke in the preceding 3 months
  • Lack of transcranial Doppler acoustic window
  • Echocardiographic projections precluding adequate measurements
  • Anemia with Hemoglobin < 8 g/dl
  • Alcohol or psychoactive agents abuse

结局指标

主要结局

Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MMSE)

时间窗: At six months from HF diagnosis

Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction according to Mini Mental State Examination (MMSE score ≥10)

次要结局

  • Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MoCA)(At six months from HF diagnosis)
  • Proportion of patients with mild cognitive dysfunction (MMSE)(At six months from HF diagnosis)
  • Proportion of patients with mild cognitive dysfunction (MoCA)(At six months from HF diagnosis)
  • Proportion of patients with moderate cognitive dysfunction (MMSE)(At six months from HF diagnosis)
  • Proportion of patients with moderate cognitive dysfunction (MoCA)(At six months from HF diagnosis)
  • Proportion of patients with moderate reduced cerebral flow velocity(At six months from HF diagnosis)
  • Proportion of patients with significantly reduced cerebral flow velocity(At six months from HF diagnosis)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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