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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Poland
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
RECRUITING
Krakow
Contact Information
Primary
Piotr Musialek, MD, DPhil
pmusialek@szpitaljp2.krakow.pl
+48126142287
Backup
Karolina Dzierwa, MD, PhD
kdzierwa@szpitaljp2.krakow.pl
+48126143158
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 300
Treatments
Isolated HF Group
Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III).
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.
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).
Related Therapeutic Areas
Heart Failure
Carotid Artery Disease
Sponsors
Leads: John Paul II Hospital, Krakow

This content was sourced from clinicaltrials.gov

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