Coronary Artery DiseasePMCDNCT06372509
A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease
An observational study of Coronary Artery Disease and Migraine, run by Centro Cardiologico Monzino at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Coronary Artery Disease, Migraine, Cardiovascular Diseases
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Adult
Study population: Consecutive patients admitted for non coronary disease, will follow their clinical pathway. They will be classified into symptomatic for migraine with aura (N=45) and free from migraine (N=45) and will be enrolled in the study.
Who may be able to join
- Age >25 years and > 60 years
- Signed patient informed consent form (ICF)
- Non-coronary disease
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan, Milan, 20131
Daniela Trabattoni, MD, 0258002780, daniela.trabattoni@cardiologicomonzino.it
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Migraine, Cardiovascular Diseases
- Medical subject headings
- Coronary Artery Disease, Migraine Disorders, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: October 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start3 Apr 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372509
- Sponsor's protocol ID
- L2-070
- Acronym
- PMCD
- Status last verified
- Apr 2024
- First submitted
- 15 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06372509
- Acronym / sponsor ID
- PMCD / L2-070
- Conditions
- Coronary Artery Disease, Migraine, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- IRCCS Policlinico S. Donato
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Consecutive patients admitted for non coronary disease, will follow their clinical pathway. They will be classified into symptomatic for migraine with aura (N=45) and free from migraine (N=45) and will be enrolled in the study.
Key inclusion criteria (3 listed)
- Age >25 years and > 60 years
- Signed patient informed consent form (ICF)
- Non-coronary disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between migraine and proteomic profiling of plasma
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Migraine, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Trabattoni, MD (0258002780, daniela.trabattoni@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between migraine and proteomic profiling of plasma (time frame: October 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.