RecruitingNCT05250349

TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure

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


Sponsor

John Paul II Hospital, Krakow

Enrollment

300 participants

Start Date

Sep 1, 2021

Study Type

OBSERVATIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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

Interventions

DIAGNOSTIC_TESTEchocardiography

Transthoracic echocardiography with standard measurements

DIAGNOSTIC_TESTDoppler sonography

Transcarotid and transcranial Doppler sonography

DIAGNOSTIC_TESTNeuropsychological tests

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


Locations(1)

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

Krakow, MP, Poland

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NCT05250349


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