Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients

NCT ID: NCT07055152

Last Updated: 2025-07-08

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

2025-01-01

Study Completion Date

2027-01-01

Brief Summary

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The aim of this study is to evaluate microvascular dysfunction through OCTA in MINOCA patients. In order to better understand the condition, OCTA will also be performed in two matched patient groups: healthy controls and ACS patients. The study will compare the retinal microvascular parameters across these groups to determine differences in microvascular function in MINOCA patients. Additionally, in the MINOCA subgroup, the study will further evaluate the differences in microvascular dysfunction within specific subsets of patients (e.g., Takotsubo, vasospastic angina, microvascular angina, patients with evidence of plaque erosion) to understand the variability and potential mechanisms underlying each subgroup of MINOCA.

Detailed Description

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Conditions

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MINOCA STEMI Normal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MINOCA

MINOCA

No interventions assigned to this group

STEMI

STEMI

No interventions assigned to this group

NORMAL

NORMAL

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age: Patients aged \> 18.

Diagnosis:

MINOCA Group: Patients diagnosed with Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA) confirmed by coronary angiography.

ACS Group: Patients with Acute Coronary Syndrome (ACS) with significant coronary artery stenosis which are matched with MINOCA patients for gender, age, LVEF at admission and chronic kidney disease stage.

Healthy Controls: Age and gender-matched healthy individuals with no history of cardiovascular disease.

Consent: Written informed consent obtained from all participants. Feasibility: Ability to undergo OCTA and other required imaging procedures.

Exclusion Criteria

* Ocular Conditions: Any significant ocular disease (e.g., glaucoma, diabetic retinopathy, macular degeneration) that could interfere with OCTA imaging quality.

Severe Comorbidities: Presence of severe systemic diseases, such as advanced renal failure, active cancer, or severe liver disease, which might impact study participation.

Coronary Artery Disease or Myocarditis: For the MINOCA group, patients with coronary artery stenosis \> 50% or functionally significant (FFR \<0.8) or patients with Myocarditis detected through CMR will be excluded Pregnancy: Pregnant or breastfeeding women. Inability to Comply: Patients unable or unwilling to comply with study procedures, including follow-up visits.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Mattia Alberti

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Pisa, Cisanello Hospital

Pisa, Pisa, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Mattia Alberti, Dr

Role: CONTACT

+393271946335

Facility Contacts

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Mattia Alberti, Dr

Role: primary

+39050995317

Other Identifiers

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REVEAL

Identifier Type: -

Identifier Source: org_study_id

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