Retinal OCTA to detect tiny blood vessel problems in people with MINOCA

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

This project will use a quick retinal OCTA scan to see if tiny blood vessel changes differ in people with MINOCA compared with heart attack patients who have blocked arteries and with healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 90 (estimated)
• Sex: All
• Sponsor: University of Pisa (other)
• Locations: 1 site (Pisa, Pisa)
• Trial ID: NCT07055152 on ClinicalTrials.gov

What this trial studies

This observational study will use optical coherence tomography angiography (OCTA) of the retina to compare microvascular parameters across three matched groups: patients with MINOCA, patients with acute coronary syndrome (ACS) with obstructive coronary disease, and healthy controls. Matching will be done for age, sex, left ventricular ejection fraction at admission, and chronic kidney disease stage to reduce confounding. Within the MINOCA group the study will look for differences between clinical subtypes (for example Takotsubo syndrome, vasospastic angina, microvascular angina, and cases with plaque erosion) to explore possible mechanisms. Retinal microvascular metrics will be analyzed to see whether they differ between groups and whether they predict outcomes in MINOCA patients.

Who should consider this trial

Good fit: Adults over 18 with confirmed MINOCA by coronary angiography, matched ACS patients, and age- and sex-matched healthy volunteers who can undergo OCTA and give written informed consent are suitable.

Not a fit: People with significant eye disease that prevents good OCTA imaging or with severe systemic illnesses that preclude participation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, a noninvasive retinal OCTA scan could help identify microvascular dysfunction and provide a biomarker to stratify risk or guide follow-up in MINOCA patients.

How similar studies have performed: Prior research has linked retinal microvascular changes on OCTA to coronary and microvascular disease, but applying OCTA specifically to compare MINOCA subtypes is relatively novel.

Eligibility criteria

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.

Where this trial is running

Pisa, Pisa

• University of Pisa, Cisanello Hospital — Pisa, Pisa, Italy (RECRUITING)

Study contacts

• Study coordinator: Mattia Alberti, Dr

Conditions: MINOCA, STEMI, Normal