| Registry | NCT07055152, acronym REVEAL |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 90 (Estimated) |
| Sponsor | University of Pisa (Other) |
| Conditions | MINOCA, STEMI, Normal |
| Dates | start 2025-01-01, primary completion 2026-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2025-07-08, last updated 2025-07-08 |
| Locations | 1 site in Italy |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| MINOCA | MINOCA | ||
| STEMI | STEMI | ||
| NORMAL | NORMAL |
Sex: All, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| University of Pisa, Cisanello Hospital | Pisa, Pisa | Italy | Recruiting |