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

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.

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Key information

Conditions

Minoca Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Normal Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pisa, Cisanello Hospital

Pisa, 56124, Italy

Location status: Recruiting

Location contact

Mattia Alberti, Dr

CONTACT

[email protected]

+39050995317

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

OCTA changes in three different courts and their correlation with clinical and imaging biomarkers

Time frame: 24 months

ETDRS Grid Parameters: The macular area will be divided into the following regions for detailed analysis:

Central (Foveal) Zone Inner Ring (split into quadrants: superior, inferior, nasal, temporal) Outer Ring (split into quadrants: superior, inferior, nasal, temporal)

Foveal Avascular Zone (FAZ): The following characteristics will be recorded:

FAZ Area (mm^2) FAZ Perimeter (mm) FAZ Circularity Index

Study contacts

Contact information is provided by the study sponsor or research team.

Mattia Alberti, Dr

CONTACT

[email protected]

+393271946335

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Acronym: REVEAL

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Jul 8, 2025
Registry last updated: Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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