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NCT06372509 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— PMCD  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06372509
Other study ID # L2-070
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 3, 2024
Est. completion date October 30, 2025

Study information
Verified date April 2024
Source Centro Cardiologico Monzino
Contact Daniela Trabattoni, MD
Phone 0258002780
Email daniela.trabattoni@cardiologicomonzino.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date October 30, 2025
Est. primary completion date October 30, 2025
Accepts healthy volunteers
Gender All
Age group 25 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Centro Cardiologico Monzino Milano Milan

Sponsors (2)
Lead Sponsor Collaborator
Centro Cardiologico Monzino IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between migraine and proteomic profiling of plasma 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 October 2025
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