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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07055152
Acronym
REVEAL
Enrollment
90
Registered
2025-07-08
Start date
2025-01-01
Completion date
2027-01-01
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MINOCA, Normal, STEMI

Brief summary

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.

Interventions

None listed

Sponsors

University of Pisa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
OCTA changes in three different courts and their correlation with clinical and imaging biomarkers24 monthsETDRS 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

Countries

Italy

Contacts

Primary ContactMattia Alberti, Dr
mattia.alberti96@outlook.it+393271946335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026