NCT05250349Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Feb 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 31 Dec 2021
- Start date
- 1 Sept 2021
- Primary completion date
- 1 Sept 2022
- Lead sponsor
- John Paul II Hospital, Krakow
- Diseases
- Heart failure, Stroke
- NCT number
- NCT05250349
What you commit to
- Study type: Observational
- Planned participants: 300
- From 1 Sept 2021 to the primary completion date, 1 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed dementia (including severe dementia - MMSE and MoCA score \<10)
Other illness
- Co-existing, severe, irreversible disease (e.g. advanced cancer)
- Psychiatric condition which may influence cognitive function
- Reversible cause of HF - tachyarrhytmic, peripartum or toxic cardiomyopathy, acute myocarditis, acute myocardial infarction
- Cerebral stroke in the preceding 3 months
Lab values
- Anemia with Hemoglobin \< 8 g/dl
Other
- Acute, decompensated HF
- Aortic stenosis
- Lack of transcranial Doppler acoustic window
- Echocardiographic projections precluding adequate measurements
- Alcohol or psychoactive agents abuse
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiac and Vascular Diseases, The John Paul II Hospital Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.