The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients With Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI). (EYE-NOCA)

Microvascular angina is thought to affect around 112 million patients worldwide. However, this figure is underestimated due to the difficulty of making the diagnosis. It is a pathology caused by an alteration in the microcirculation of the heart muscle, which is not detectable on a standard coronary angiogram.

In view of its prognostic, therapeutic and medico-economic value, scientific societies currently recommend invasive measurement of the microcirculatory resistance index (MRI) to diagnose microvascular angina, in the absence of significant lesions on coronary angiography.

Several research teams, including our own, have shown that cardiovascular risk is associated with alterations in the vascularization of the small vessels (microcirculation) of the retina. Unlike the study of cardiac vessels, the study of retinal microcirculation using fundus photography (OCT-A) is simple, rapid, non-invasive and inexpensive. It appears to be an interesting alternative to the measurement of IMR for the diagnosis of microvascular angina.

This hypothesis has never yet been tested. The demonstration of an association between a decrease in retinal vascular density measured by OCT-A and an alteration in coronary microvascular function measured by IMR would pave the way for a completely non-invasive diagnosis of patients.

This is an observational, cohort, prospective, single-center pilot study comparing people who have received an IMR measurement as part of INOCA.

It is planned to include 158 participants. The overall follow-up period for each patient in the research is 12 months.

In routine care, IMR is measured during coronary angiography in patients presenting with ischemia on a non-invasive test and/or stress symptoms such as angina or dyspnea, for whom coronary angiography does not reveal any significant epicardial lesion.

Following this examination, two groups will be formed: a group with an IMR<25 and a group with an IMR≥25. Clinically, the study aims to determine the potential role of retinal OCT-A as a non-invasive examination for the diagnosis and/or follow-up of INOCA.

Study Overview

• Status: Recruiting
• Conditions: Microvascular Angina
• Intervention / Treatment: Biological: Blood sampling; Procedure: Ophthalmological examination; Other: angina severity questionnaire

• Study Type: Observational
• Enrollment (Estimated): 158

Contacts and Locations

• Study Contact: Name: Pierre GUILLEMINOT; Phone Number: 0380293031; Email: pierre.guilleminot@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Pierre GUILLEMINOT; Phone Number: 0380293031; Email: pierre.guilleminot@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated at Dijon University Hospital, who received an IMR measurement as part of INOCA

Description

Inclusion Criteria:

• Patients managed at Dijon University Hospital, having had an IMR measurement as part of INOCA during a coronary angiographic examination, consecutively includible, without angiographically or functionally significant coronary epicardial lesion (FFR < 0.80) explaining the clinical picture (= INOCA)
• Person having given oral consent
• Adult

Exclusion Criteria:

• Person not affiliated or not benefiting from a social security scheme
• Person subject to a legal protection measure (curatorship, guardianship) or a safeguard of justice measure
• Pregnant or breast-feeding women
• An adult incapable or unable to give consent
• Person with macular or retinal pathology, or severe bilateral myopia
• Person with genetic or idiopathic cardiomyopathy (dilated, hypertrophic or restrictive cardiomyopathy)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IMR<25; People without microvascular angina	Biological: Blood sampling; 2 tubes of 5 mL; Procedure: Ophthalmological examination; angiographic optical coherence tomography (OCT-A) on both eyes after pupil dilation. An optional 20-30 minute WLR may be offered following OCT-A.; Other: angina severity questionnaire; at inclusion, 3 months and 1 year Estimated filling time: 2 minutes
IMR≥25; People with microvascular angina	Biological: Blood sampling; 2 tubes of 5 mL; Procedure: Ophthalmological examination; angiographic optical coherence tomography (OCT-A) on both eyes after pupil dilation. An optional 20-30 minute WLR may be offered following OCT-A.; Other: angina severity questionnaire; at inclusion, 3 months and 1 year Estimated filling time: 2 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retinal vascular density by "inner vessel length density" determined by OCT-A	At baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Angina Pectoris; Microvascular Angina; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: POMMIER J'InvEST-I 2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No