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NCT Number: NCT05250349

TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Krakow, MP, 31-202, Poland

Location status: Recruiting

Location contact

Piotr Musialek, MD, DPhil

CONTACT

[email protected]

+48126142287

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Echocardiography

Diagnostic Test

Transthoracic echocardiography with standard measurements

Doppler sonography

Diagnostic Test

Transcarotid and transcranial Doppler sonography

Neuropsychological tests

Diagnostic Test

Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)

Primary outcomes

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

    Time frame: 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)

Secondary outcomes

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

    Time frame: At six months from HF diagnosis

    Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score ≥10)

  2. Proportion of patients with mild cognitive dysfunction (MMSE)

    Time frame: At six months from HF diagnosis

    Proportion of patients with mild cognitive dysfunction according to Mini Mental State Examination (MMSE score 20 - 25)

  3. Proportion of patients with mild cognitive dysfunction (MoCA)

    Time frame: At six months from HF diagnosis

    Proportion of patients with mild cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 18 - 25)

  4. Proportion of patients with moderate cognitive dysfunction (MMSE)

    Time frame: At six months from HF diagnosis

    Proportion of patients with moderate cognitive dysfunction according to Mini Mental State Examination (MMSE score 10 - 19)4. Proportion of patients with moderate cognitive dysfunction according to Mini Mental State Examination (MMSE score 10 - 19)

  5. Proportion of patients with moderate cognitive dysfunction (MoCA)

    Time frame: At six months from HF diagnosis

    Proportion of patients with moderate cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 10 - 17)

  6. Proportion of patients with moderate reduced cerebral flow velocity

    Time frame: At six months from HF diagnosis

    Proportion of patients with reduced cerebral flow velocity (mean cerebral flow velocity <50 cm/s) in the middle cerebral artery among those with at least moderate (i.e. mild or moderate) cognitive dysfunction according to MMSE (MMSE score ≥10)

  7. Proportion of patients with significantly reduced cerebral flow velocity

    Time frame: At six months from HF diagnosis

    Proportion of patients with reduced cerebral flow velocity (mean cerebral flow velocity <50 cm/s) in the middle cerebral artery among those with at least moderate (i.e. mild or moderate) cognitive dysfunction according to MoCA tests (MoCA score≥10)

Study contacts

Contact information is provided by the study sponsor or research team.

Karolina Dzierwa, MD, PhD

CONTACT

[email protected]

+48126143158

Piotr Musialek, MD, DPhil

CONTACT

[email protected]

+48126142287

Sponsors and collaborators

Lead sponsor

John Paul II Hospital, Krakow

Other

Registry information

Official study title

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

Acronym: TRACE-IMPAIR

Important dates

Study start
2021
Primary completion
2022
Study completion
2027
First posted
Feb 22, 2022
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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