NCT07055152 Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients
| NCT ID | NCT07055152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pisa |
| Condition | MINOCA |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2025-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07055152 clinical trial?
This trial is open to participants of all sexes, studying MINOCA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07055152 currently recruiting?
Yes, NCT07055152 is actively recruiting participants. Contact the research team at mattia.alberti96@outlook.it for enrollment information.
Where is the NCT07055152 trial being conducted?
This trial is being conducted at Pisa, Italy.
Who is sponsoring the NCT07055152 clinical trial?
NCT07055152 is sponsored by University of Pisa. The trial plans to enroll 90 participants.