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NCT Number: NCT06692751

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).

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Pierre GUILLEMINOT

CONTACT

[email protected]

0380293031

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood sampling

Biological

2 tubes of 5 mL

Ophthalmological examination

Procedure

angiographic optical coherence tomography (OCT-A) on both eyes after pupil dilation.

An optional 20-30 minute WLR may be offered following OCT-A.

angina severity questionnaire

Other

at inclusion, 3 months and 1 year Estimated filling time: 2 minutes

Primary outcomes

  1. Retinal vascular density by "inner vessel length density" determined by OCT-A

    Time frame: At baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre GUILLEMINOT

CONTACT

[email protected]

0380293031

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: EYE-NOCA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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