MINOCAREVEALNCT07055152
Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients
An observational study of MINOCA and STEMI, run by University of Pisa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 1 Jan 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University of Pisa, Cisanello Hospital
Pisa, Pisa, 56124
Mattia Alberti, Dr, +39050995317, mattia.alberti96@outlook.it
About this study
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.
- Medical subject headings
- MINOCA, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MINOCA | MINOCA | |
| STEMI | STEMI | |
| NORMAL | NORMAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MINOCAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattia Alberti, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055152
- Sponsor's protocol ID
- REVEAL
- Acronym
- REVEAL
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Shared upon reasonable requests
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal OCTA for Microvascular Dysfunction Evaluation and Outcome Prediction in MINOCA Patients
- ClinicalTrials.gov ID
- NCT07055152
- Acronym / sponsor ID
- REVEAL / REVEAL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MINOCA | – | –MINOCA |
| STEMI | – | –STEMI |
| NORMAL | – | –NORMAL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age: Patients aged > 18.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OCTA changes in three different courts and their correlation with clinical and imaging biomarkers
Time frame: 24 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Undecided. Shared upon reasonable requests
Related trials for MINOCA
RecruitingObservational study
Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries
Myocardial Infarction, Coronary Microvascular Dysfunction
RecruitingPhase 2
Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.
Myocardial Infarction, Acute, Myocardial Infarction With Nonobstructive Coronary Arteries
RecruitingObservational study
Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation
Acute Coronary Syndrome, Myocardium; Injury
RecruitingObservational study
Barts-MINOCA Registry
Myocardial Infarction, Gender
Active, not recruitingObservational study
Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance
Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MINOCA and STEMI, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattia Alberti, Dr (+393271946335, mattia.alberti96@outlook.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCTA changes in three different courts and their correlation with clinical and imaging biomarkers (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.