Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, MP, 31-202, Poland
Location status: Recruiting
NCT Number: NCT05250349
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Krakow, MP, 31-202, Poland
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Transthoracic echocardiography with standard measurements
Transcarotid and transcranial Doppler sonography
Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (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 Mini Mental State Examination (MMSE score ≥10)
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)
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)
Time frame: At six months from HF diagnosis
Proportion of patients with mild cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 18 - 25)
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)
Time frame: At six months from HF diagnosis
Proportion of patients with moderate cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 10 - 17)
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)
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)
Contact information is provided by the study sponsor or research team.
Karolina Dzierwa, MD, PhD
CONTACT
Piotr Musialek, MD, DPhil
CONTACT
John Paul II Hospital, Krakow
Other
TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence/Absence of Atherosclerotic Carotid Artery Stenosis
Acronym: TRACE-IMPAIR
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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