TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure

NCT05250349 | Recruiting

• 1 other identifier: TRACE-IMPAIR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Cognitive Impairment; Carotid Stenosis

Keywords

Carotid Stenosis; Heart Failure; Carotid Doppler; Transcranial Doppler; Cerebral Flow; Cognitive Impairment; Stroke Volume

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MMSE)

  Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction according to Mini Mental State Examination (MMSE score ≥10)

  At six months from HF diagnosis

Secondary Outcomes (7)

• Proportion of patients with at least moderate (i.e. mild or moderate) cognitive dysfunction (MoCA)

  At six months from HF diagnosis

• Proportion of patients with mild cognitive dysfunction (MMSE)

  At six months from HF diagnosis

• Proportion of patients with mild cognitive dysfunction (MoCA)

  At six months from HF diagnosis

• Proportion of patients with moderate cognitive dysfunction (MMSE)

  At six months from HF diagnosis

• Proportion of patients with moderate cognitive dysfunction (MoCA)

  At six months from HF diagnosis

Study Arms (3)

Isolated HF Group

Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III).

Diagnostic Test: Echocardiography; Diagnostic Test: Doppler sonography; Diagnostic Test: Neuropsychological tests

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.

Diagnostic Test: Echocardiography; Diagnostic Test: Doppler sonography; Diagnostic Test: Neuropsychological tests

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).

Diagnostic Test: Echocardiography; Diagnostic Test: Doppler sonography; Diagnostic Test: Neuropsychological tests

Interventions

Echocardiography DIAGNOSTIC_TEST

Transthoracic echocardiography with standard measurements

Control group; HF + CS group; Isolated HF Group

Doppler sonography DIAGNOSTIC_TEST

Transcarotid and transcranial Doppler sonography

Control group; HF + CS group; Isolated HF Group

Neuropsychological tests DIAGNOSTIC_TEST

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

Control group; HF + CS group; Isolated HF Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comers registry of patients with HF with mildly reduced (41-49% - HFmrEF) and reduced left ventricle ejection fraction (≤40% - HFrEF)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead

Study Sites (1)

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

Krakow, MP, 31-202, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction; Carotid Stenosis

Interventions

Echocardiography; Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Echoencephalography; Neuroradiography; Neuroimaging; Radiography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Piotr Musialek, MD, DPhil

  John Paul II Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Musialek, MD, DPhil

CONTACT

+48126142287; pmusialek@szpitaljp2.krakow.pl

Karolina Dzierwa, MD, PhD

CONTACT

+48126143158; kdzierwa@szpitaljp2.krakow.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: February 22, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

PL (1)