Skip to main content
Clinical Trials/NCT04549298
NCT04549298
Unknown
Not Applicable

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

Neuromed IRCCS0 sites88 target enrollmentOctober 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Left Ventricular Diastolic Dysfunction
Sponsor
Neuromed IRCCS
Enrollment
88
Primary Endpoint
Measurement of white matter hyperintensities volume
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2022
End Date
October 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Neuromed IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Giuseppe Lembo

Full Professor, MD, PhD

Neuromed IRCCS

Eligibility Criteria

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
  • previous carotid artery stenting or carotid surgery
  • inability to be subjected MRI analysis

Outcomes

Primary Outcomes

Measurement of white matter hyperintensities volume

Time Frame: At Enrollment

Brain MRI

Secondary Outcomes

  • Characterization of cardiac overload with blood markers(At Enrollment)
  • Detection of plaques and carotid atherosclerosis(At Enrollment)
  • Detection of cognitive decline by decrease of MoCA score(At Enrollment)

Similar Trials