Microvascular AnginaEYE-NOCANCT06692751
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).
An observational study of Microvascular Angina, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microvascular Angina
- What is being tested?
- Blood sampling, Ophthalmological examination and angina severity questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2024to Nov 2029
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at Dijon University Hospital, who received an IMR measurement as part of INOCA
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Pierre GUILLEMINOT, 0380293031, pierre.guilleminot@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Microvascular Angina
- Being tested
- Blood sampling, Ophthalmological examination, angina severity questionnaire
- Medical subject headings
- Microvascular Angina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
2 tubes of 5 mL
Ophthalmological examinationProcedure or surgery
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 questionnaireOther
at inclusion, 3 months and 1 year Estimated filling time: 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| IMR<25 | People without microvascular angina Receives: Biological: Blood sampling; Procedure: Ophthalmological examination; Other: angina severity questionnaire | |
| IMR≥25 | People with microvascular angina Receives: Biological: Blood sampling; Procedure: Ophthalmological examination; Other: angina severity questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vascular density by "inner vessel length density" determined by OCT-A
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start13 Nov 2024
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microvascular AnginaStudies 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692751
- Sponsor's protocol ID
- POMMIER J'InvEST-I 2023
- Acronym
- EYE-NOCA
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No