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

NCT04549298 | Unknown

• 1 other identifier: LMB09
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Left Ventricular Diastolic Dysfunction

Keywords

Diastolic dysfunction; White matter hyperintensities; Carotid atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Measurement of white matter hyperintensities volume

  Brain MRI

  At Enrollment

Secondary Outcomes (3)

• Detection of plaques and carotid atherosclerosis

  At Enrollment

• Characterization of cardiac overload with blood markers

  At Enrollment

• Detection of cognitive decline by decrease of MoCA score

  At Enrollment

Study Arms (2)

Patients with grade 2 and 3 LV diastolic dysfunction

Patients with high filling pressure

Other: No interventions

Patients with normal and grade 1 LV diastolic dysfunction

Patients with normal filling pressure

Other: No interventions

Interventions

No interventions OTHER

No interventions - observational study

Patients with grade 2 and 3 LV diastolic dysfunction; Patients with normal and grade 1 LV diastolic dysfunction

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 88 subjects of both genders will be included in the study.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuromed IRCCS: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Central Study Contacts

Giuseppe Lembo, MD, PhD

CONTACT

+390865915225; lembo@neuromed.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, MD, PhD

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share