A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease (PMCD)

Centro Cardiologico Monzino

Status: Enrolling

Conditions: Coronary Artery Disease; Cardiovascular Diseases; Migraine

Study type: Observational

Funder types: Other

Identifiers

NCT06372509

L2-070

Details and patient eligibility

About

This is a multicenter, prospective observational study. Will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our Hospital. Primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and Cardiovascular (CV) risk factors.

Full description

Ninety consecutive patients hospitalized for noncoronary artery disease will follow their clinical course. They will be classified into symptomatic for migraine with aura (N=45) and migraine free (N=45) and will be enrolled in the study. Patients will be screened for migraine characteristics and a comprehensive clinical analysis, including sex-related cardiovascular risk factors, will be collected. To achieve the study objective, blood will be drawn to do targeted proteomic evaluation of proteins relevant to Cardiovascular disease (CVD), inflammation, immune response, and neurological disorders, in order to compare the profile of migraine patients with that obtained in patients without migraine.

Enrollment: 90 estimated patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >25 years and > 60 years
• Signed patient informed consent form (ICF)
• Non-coronary disease

Exclusion criteria

• Age < 25 years and > 60 years
• Acute myocardial infarction (MI)
• Chronic kidney disease: glomerular filtration rate (GFR) < 30 ml/min
• Severe mitral or aortic valvular disease
• Acute heart failure
• Reduced left ventricular (LV) function (Ejection Fraction < 35%)
• Atrial Fibrillation

Trial design

90 participants in 2 patient groups

Patients with migraine

Description:

Consecutive patients admitted for non coronary disease, will follow their clinical pathway. They will be classified into symptomatic for migraine with aura (group 1, N=45) and free from migraine (N=45) and will be enrolled in the study.

Patients w/o migraine

Description:

Consecutive patients admitted for non coronary disease, will follow their clinical pathway. They will be classified into free from migraine (group 2, N=45) and will be enrolled in the study.