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NCT06692751Recruiting

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).

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
52 (estimated)
First submitted
15 Nov 2024
Start date
13 Nov 2024
Primary completion date
Nov 2029
Lead sponsor
Centre Hospitalier Universitaire Dijon
NCT number
NCT06692751

What you commit to

  • Study type: Observational
  • Planned participants: 52
  • From 13 Nov 2024 to the primary completion date, Nov 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Dijon Bourgogne
Coordinator of this site? Confirm its status
DijonFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.