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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06372509

Acronym

PMCD

Enrollment

Registered

2024-04-18

Start date

2024-04-03

Completion date

2025-10-30

Last updated

2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Artery Disease, Migraine

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactDaniela Trabattoni, MD

daniela.trabattoni@cardiologicomonzino.it0258002780

Backup ContactCristina Banfi, PhD

cristina.banfi@cardiologicomonzino.it0258002403

Outcome results