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

NCT ID: NCT06372509

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-03

Study Completion Date

2025-10-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Migraine Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with migraine

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.

No interventions assigned to this group

Patients w/o migraine

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro Cardiologico Monzino

Milan, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Daniela Trabattoni, MD

Role: CONTACT

0258002780

Cristina Banfi, PhD

Role: CONTACT

0258002403

Facility Contacts

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Daniela Trabattoni, MD

Role: primary

0258002780

Other Identifiers

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L2-070

Identifier Type: -

Identifier Source: org_study_id

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