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RecruitingNCT07055152REVEALUpdated Jul 8, 2025

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

An observational study in MINOCA, STEMI and Normal, sponsored by University of Pisa. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by University of Pisa · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Sex
All
01

Study 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.

02

Conditions studied

  • MINOCA
  • STEMI
  • Normal
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

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.

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • MINOCA

    MINOCA

  • STEMI

    STEMI

  • NORMAL

    NORMAL

05

What researchers measure

Primary outcomes

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

    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

    Time frame: 24 months

06

Study locations

1 of 1 sites recruiting
  • University of Pisa, Cisanello Hospital
    Pisa, Pisa 56124, Italy
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — Shared upon reasonable requests

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07055152
Lead sponsor
University of Pisa
Responsible party
Mattia Alberti (Principal Investigator, University of Pisa) — Principal investigator
First posted
Jul 8, 2025
Start date
Jan 1, 2025
Primary completion
Jan 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jul 8, 2025

Study contacts

Mattia Alberti, Dr
Contact
mattia.alberti96@outlook.it
+393271946335

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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