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Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage

Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04549298
Enrollment
88
Registered
2020-09-16
Start date
2022-10-31
Completion date
2023-10-31
Last updated
2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Ventricular Diastolic Dysfunction

Keywords

Diastolic dysfunction, White matter hyperintensities, Carotid atherosclerosis

Brief summary

Left ventricular diastolic dysfunction is caused by impaired relaxation and increased left ventricular stiffness with a consequent increase in filling pressures. Currently, it is possible to classify it in 3 grades: grade 1 with normal filling pressures, grade 2 and grade 3 with high pressures. Diastolic dysfunction is closely associated with several risk factors such as hypertension, diabetes, and obesity, as well as the risk of heart failure, cardiovascular events, and death. In the field of cerebrovascular diseases, however, diastolic dysfunction is still being researched. Thus, this study aims to: 1) evaluate the white matter hyperintensities volume in association with the increase of diastolic dysfunction and filling pressures 2) evaluate the possible association with carotid atherosclerosis in case of brain damage caused by dysfunction diastolic 3) understand the mechanism of damage caused by left ventricular diastolic dysfunction on the cerebrovascular system. In order to do this, this study proposes to evaluate in a cohort of patients, between 35 and 65 years, the possible association of diastolic dysfunction with lesions on the cerebrovascular system in a future view of new marker of brain damage and new modifiable risk factor.

Interventions

OTHERNo interventions

No interventions - observational study

Sponsors

Neuromed IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* age ≥ 35 and ≤ 65 years * written informed consent

Exclusion criteria

* previous stroke or TIA * arrhythmia or severe cardiac disease * renal disease * psychiatric disease * neurological or neurodegenerative disease * dementia * previous carotid artery stenting or carotid surgery * inability to be subjected MRI analysis

Design outcomes

Primary

MeasureTime frameDescription
Measurement of white matter hyperintensities volumeAt EnrollmentBrain MRI

Secondary

MeasureTime frameDescription
Detection of plaques and carotid atherosclerosisAt EnrollmentUltrasound of the supraortic trunks
Characterization of cardiac overload with blood markersAt EnrollmentNT-proBNP
Detection of cognitive decline by decrease of MoCA scoreAt EnrollmentCognitive tests

Contacts

Primary ContactGiuseppe Lembo, MD, PhD
lembo@neuromed.it+390865915225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026