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

Sponsor

Neuromed IRCCS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04549298

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Ventricular Diastolic Dysfunction	Other: No interventions

Study Design

Study Type:

Observational

Anticipated Enrollment :

88 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with grade 2 and 3 LV diastolic dysfunction Patients with high filling pressure	Other: No interventions No interventions - observational study
Patients with normal and grade 1 LV diastolic dysfunction Patients with normal filling pressure	Other: No interventions No interventions - observational study

Arm

Intervention/Treatment

Patients with grade 2 and 3 LV diastolic dysfunction

Patients with high filling pressure

Other: No interventions

No interventions - observational study

Patients with normal and grade 1 LV diastolic dysfunction

Patients with normal filling pressure

Other: No interventions

No interventions - observational study

Outcome Measures

Primary Outcome Measures

Measurement of white matter hyperintensities volume [At Enrollment]
Brain MRI

Secondary Outcome Measures

Detection of plaques and carotid atherosclerosis [At Enrollment]
Ultrasound of the supraortic trunks
Characterization of cardiac overload with blood markers [At Enrollment]
NT-proBNP
Detection of cognitive decline by decrease of MoCA score [At Enrollment]
Cognitive tests

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Neuromed IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giuseppe Lembo, Full Professor, MD, PhD, Neuromed IRCCS

ClinicalTrials.gov Identifier:

NCT04549298

Other Study ID Numbers:

LMB09

First Posted:

Sep 16, 2020

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Giuseppe Lembo, Full Professor, MD, PhD, Neuromed IRCCS

Diastolic dysfunction

White matter hyperintensities

Carotid atherosclerosis

Additional relevant MeSH terms:

Carotid Artery Diseases

Atherosclerosis

Ventricular Dysfunction, Left

Study Results

No Results Posted as of Apr 11, 2022