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

Recruiting

• Conditions: Migraine; Coronary Artery Disease; Cardiovascular Diseases

• Registration Number: NCT06372509
• Lead Sponsor: Centro Cardiologico Monzino

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-03
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-18
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between migraine and proteomic profiling of plasma	October 2025	A blood sample will be obtained to perform a targeted proteomic assessment of proteins relevant in CVD, inflammation, immune response and neurological disorders in order to compare migraineurs patients profile with the one obtained in migraine-free patients

Trial Locations

Locations (1)

Centro Cardiologico Monzino; 🇮🇹 Milano, Milan, Italy