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

NCT07055152 | Recruiting

• 1 other identifier: REVEAL
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

MINOCA; STEMI; Normal

Outcome Measures

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

  24 months

Study Arms (3)

MINOCA

MINOCA

STEMI

STEMI

NORMAL

NORMAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa, Cisanello Hospital

Pisa, Pisa, 56124, Italy

RECRUITING

MeSH Terms

Conditions

MINOCA; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Mattia Alberti, Dr

CONTACT

+393271946335; mattia.alberti96@outlook.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 8, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

IT (1)