Heart FailureTRACE-IMPAIRNCT05250349
TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure
An observational study of Heart Failure and Cognitive Impairment, run by John Paul II Hospital, Krakow at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cognitive Impairment, Carotid Stenosis
- What is being tested?
- Echocardiography, Doppler sonography and Neuropsychological tests
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2021to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers registry of patients with HF with mildly reduced (41-49% - HFmrEF) and reduced left ventricle ejection fraction (≤40% - HFrEF)
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, MP, 31-202
Piotr Musialek, MD, DPhil, +48126142287, pmusialek@szpitaljp2.krakow.pl
About this study
Official title: TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence/Absence of Atherosclerotic Carotid Artery Stenosis
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.
Read the detailed description
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).
- Conditions
- Heart Failure, Cognitive Impairment, Carotid Stenosis
- Being tested
- Echocardiography, Doppler sonography, Neuropsychological tests
- Keywords
- Carotid Stenosis, Heart Failure, Carotid Doppler, Transcranial Doppler, Cerebral Flow, Cognitive Impairment, Stroke Volume
- Medical subject headings
- Heart Failure, Cognitive Dysfunction, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Transthoracic echocardiography with standard measurements
Doppler sonographyDiagnostic test
Transcarotid and transcranial Doppler sonography
Neuropsychological testsDiagnostic test
Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)
| Study group | Role | What they receive |
|---|---|---|
| Isolated HF Group | Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III). Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Doppler sonography; Diagnostic Test: Neuropsychological tests | |
| HF + CS group | 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. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Doppler sonography; Diagnostic Test: Neuropsychological tests | |
| Control group | A cohort of patients without Heart Failure or other significant cardiac pathology and without Carotid Stenosis (a paired propensity match will be performed). Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Doppler sonography; Diagnostic Test: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At six months from HF diagnosis
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At six months from HF diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Musialek, MD, DPhil, Principal investigator, John Paul II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250349
- Sponsor's protocol ID
- TRACE-IMPAIR
- Acronym
- TRACE-IMPAIR
- Status last verified
- Feb 2022
- First submitted
- 31 Dec 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence/Absence of Atherosclerotic Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT05250349
- Acronym / sponsor ID
- TRACE-IMPAIR / TRACE-IMPAIR
- Conditions
- Heart Failure, Cognitive Impairment, Carotid Stenosis
- Keywords
- Carotid Stenosis, Heart Failure, Carotid Doppler, Transcranial Doppler, Cerebral Flow, Cognitive Impairment, Stroke Volume
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isolated HF Group | – | Diagnostic Test: Echocardiography, Diagnostic Test: Doppler sonography, Diagnostic Test: Neuropsychological testsPatients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III). |
| HF + CS group | – | Diagnostic Test: Echocardiography, Diagnostic Test: Doppler sonography, Diagnostic Test: Neuropsychological testsPatients 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. |
| Control group | – | Diagnostic Test: Echocardiography, Diagnostic Test: Doppler sonography, Diagnostic Test: Neuropsychological testsA cohort of patients without Heart Failure or other significant cardiac pathology and without Carotid Stenosis (a paired propensity match will be performed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers registry of patients with HF with mildly reduced (41-49% - HFmrEF) and reduced left ventricle ejection fraction (≤40% - HFrEF)
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyTransthoracic echocardiography with standard measurements | Diagnostic test | Control group, HF + CS group, Isolated HF Group |
| Doppler sonographyTranscarotid and transcranial Doppler sonography | Diagnostic test | Control group, HF + CS group, Isolated HF Group |
| Neuropsychological testsMini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) | Diagnostic test | Control group, HF + CS group, Isolated HF Group |
Primary outcome
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)
7 secondary outcomes
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 mild cognitive dysfunction (MMSE)
Time frame: At six months from HF diagnosis
Proportion of patients with mild cognitive dysfunction (MoCA)
Time frame: At six months from HF diagnosis
Proportion of patients with moderate cognitive dysfunction (MMSE)
Time frame: At six months from HF diagnosis
Proportion of patients with moderate cognitive dysfunction (MoCA)
Time frame: At six months from HF diagnosis
Proportion of patients with moderate reduced cerebral flow velocity
Time frame: At six months from HF diagnosis
Proportion of patients with significantly reduced cerebral flow velocity
Time frame: At six months from HF diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piotr Musialek, MD, DPhil principal investigator
John Paul II Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cognitive Impairment, run by John Paul II Hospital, Krakow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Musialek, MD, DPhil (+48126142287, pmusialek@szpitaljp2.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MMSE) (time frame: At six months from HF diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.