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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

From the registry’s dates

  • Primary completion was expected by Jan 2026, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Sex
All
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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

In context

MINOCA

29 studies on the registry are indexed under MINOCA; 18 are open to participants now.

This study's planned enrollment of 90 is below the median of 500 across 20 observational studies indexed under MINOCA.

Browse MINOCA studies →

Lead sponsor

University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, at admission and chronic kidney disease stage.

Healthy Controls: Age and gender-matched healthy individuals with no history of cardiovascular disease.

Consent: Written 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Shared upon reasonable requests

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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