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
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.
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.
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:
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.
MINOCA
STEMI
NORMAL
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
Plan to share: Undecided — Shared upon reasonable requests
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University of Pisa