An observational study in Heart Failure, Cognitive Impairment and Carotid Stenosis, sponsored by John Paul II Hospital, Krakow. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by John Paul II Hospital, Krakow · Observational
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.
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).
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →John Paul II Hospital, Krakow is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All-comers registry of patients with HF with mildly reduced (41-49% - HFmrEF) and reduced left ventricle ejection fraction (≤40% - HFrEF)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III).
Diagnostic Test: Echocardiography · Diagnostic Test: Doppler sonography · Diagnostic Test: Neuropsychological tests
Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) with NYHA I-III symptoms, who were diagnosed with flow limiting Carotid Stenosis on carotid Doppler ultrasound.
Diagnostic Test: Echocardiography · Diagnostic Test: Doppler sonography · Diagnostic Test: Neuropsychological tests
A cohort of patients without Heart Failure or other significant cardiac pathology and without Carotid Stenosis (a paired propensity match will be performed).
Diagnostic Test: Echocardiography · Diagnostic Test: Doppler sonography · Diagnostic Test: Neuropsychological tests
Transthoracic echocardiography with standard measurements
Transcarotid and transcranial Doppler sonography
Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)
Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MMSE)
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 (MoCA)
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 (MMSE)
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 (MoCA)
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 (MMSE)
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 (MoCA)
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 moderate reduced cerebral flow velocity
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 significantly reduced cerebral flow velocity
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)
Time frame: At six months from HF diagnosis
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2021 (actual). Primary completion is estimated for Sep 2022, 12 months after the start.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 12 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
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John Paul II Hospital, Krakow