Actively Recruiting

All Genders
Healthy Volunteers
ID07055152

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

Led by University of Pisa · Updated on 2025-07-08

90

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying microvascular dysfunction in patients with Myocardial Infarction with Non-Obstructive Coronary Arteries (MINOCA) by using Optical Coherence Tomography Angiography (OCTA). The study also includes healthy individuals and patients with Acute Coronary Syndrome (ACS) to compare retinal microvascular parameters across these groups. The goal is to better understand differences in microvascular function and the variability within specific MINOCA subgroups such as Takotsubo, vasospastic angina, microvascular angina, and plaque erosion cases. This observational study involves three groups: MINOCA patients confirmed by coronary angiography, ACS patients with significant coronary artery stenosis matched to MINOCA patients, and age- and gender-matched healthy controls without cardiovascular disease. Participants will undergo OCTA and other imaging procedures to assess their retinal microvascular function. The study will observe these groups over 24 months to evaluate OCTA changes and their correlation with clinical and imaging biomarkers. Participants will provide written informed consent and attend follow-up visits for imaging and assessments. Researchers will monitor changes in retinal microvascular function using OCTA and review clinical and imaging data to understand microvascular dysfunction in MINOCA and comparison groups. The study excludes those with significant eye diseases, severe systemic illnesses, myocarditis, or pregnancy, ensuring participants can comply with all procedures during the observation period.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged over 18 years
  • Diagnosis of MINOCA confirmed by coronary angiography for the MINOCA group
  • Patients with Acute Coronary Syndrome with significant coronary artery stenosis matched to MINOCA patients for gender, age, LVEF at admission, and chronic kidney disease stage
  • Healthy individuals matched for age and gender with no history of cardiovascular disease
  • Written informed consent obtained
  • Ability to undergo OCTA and required imaging procedures
Not Eligible

You will not qualify if you...

  • Significant ocular diseases such as glaucoma, diabetic retinopathy, or macular degeneration that affect OCTA imaging
  • Severe systemic diseases including advanced renal failure, active cancer, or severe liver disease
  • For MINOCA group: coronary artery stenosis greater than 50% or functionally significant stenosis (FFR less than 0.8), or myocarditis detected by cardiac MRI
  • Pregnant or breastfeeding women
  • Inability or unwillingness to comply with study procedures including follow-up visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Initial assessment period

Participants undergo retinal OCTA imaging and other required imaging procedures to evaluate microvascular function.

1 visit (in-person)

Long-term Monitoring

Duration - 24 months

Participants are monitored over time to observe changes in retinal OCTA and correlate with clinical and imaging biomarkers.

Periodic visits during the 24 months

Trial Site Locations

Total: 1 location

1

University of Pisa, Cisanello Hospital

Pisa, Pisa, Italy, 56124

Actively Recruiting

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Research Team

M

Mattia Alberti, Dr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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