TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure
Recruiting · NCT05250349 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Doppler sonographyEchocardiographyNeuropsychological tests
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Department of Cardiac and Vascular Diseases, The John Paul II Hospital - Krakow, MP, Poland