TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure (TRACE-IMPAIR)

February 10, 2022 updated by: John Paul II Hospital, Krakow

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • MP
      • Kraków, MP, Poland, 31-202
        • Recruiting
        • Department of Cardiac and Vascular Diseases, The John Paul II Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All-comers registry of patients with HF with mildly reduced (41-49% - HFmrEF) and reduced left ventricle ejection fraction (≤40% - HFrEF)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Isolated HF Group
Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III).
Diagnostic test: Echocardiography
Transthoracic echocardiography with standard measurements
Diagnostic test: Doppler sonography
Transcarotid and transcranial Doppler sonography
Diagnostic test: Neuropsychological tests
Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)
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.
Diagnostic test: Echocardiography
Transthoracic echocardiography with standard measurements
Diagnostic test: Doppler sonography
Transcarotid and transcranial Doppler sonography
Diagnostic test: Neuropsychological tests
Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)
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).
Diagnostic test: Echocardiography
Transthoracic echocardiography with standard measurements
Diagnostic test: Doppler sonography
Transcarotid and transcranial Doppler sonography
Diagnostic test: Neuropsychological tests
Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At six months from HF diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 according to Mini Mental State Examination (MMSE score 20 - 25)
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 mild cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 18 - 25)
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 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)
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 cognitive dysfunction according to Montreal Cognitive Assessment (MoCA score 10 - 17)
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 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)
At six months from HF diagnosis
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)
At six months from HF diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Paul II Hospital, Krakow

Investigators

  • Principal Investigator: Piotr Musialek, MD, DPhil, John Paul II Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2027

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 10, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRACE-IMPAIR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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