Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: MINOCA, STEMI, Normal. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- OCTA changes in three different courts and their correlation with clinical and imaging biomarkers [Time frame: 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University of Pisa, Cisanello Hospital — Pisa
Identifiers
NCT: NCT07055152 · REVEAL