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Clinical Trials in Poland / NCT05250349
Recruiting Observational

TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure

NCT05250349 · tracked via the Priya Life Science Poland tracker
Sponsor
John Paul II Hospital, Krakow
Phase
Observational
Started
2021-09-01
Last updated
2022-02-22

Condition(s) studied

Heart FailureCognitive ImpairmentCarotid Stenosis

Investigational drug(s) / intervention(s)

EchocardiographyDoppler sonographyNeuropsychological tests

Echocardiography: Transthoracic echocardiography with standard measurements

Doppler sonography: Transcarotid and transcranial Doppler sonography

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Cardiac and Vascular Diseases, The John Paul II Hospital Krakow MP Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05250349 on ClinicalTrials.gov ↗ ← All trials in Poland