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

Left Ventricular Diastolic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04549298
• Other study ID #: LMB09
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2023

Study information

• Verified date: April 2022
• Source: Neuromed IRCCS
• Contact: Giuseppe Lembo, MD, PhD
• Phone: +390865915225
• Email: lembo[@]neuromed.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Left Ventricular Diastolic Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• No interventions
No interventions - observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of white matter hyperintensities volume	Brain MRI	At Enrollment
Secondary	Detection of plaques and carotid atherosclerosis	Ultrasound of the supraortic trunks	At Enrollment
Secondary	Characterization of cardiac overload with blood markers	NT-proBNP	At Enrollment
Secondary	Detection of cognitive decline by decrease of MoCA score	Cognitive tests	At Enrollment