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).

NCT06692751 | Recruiting

• 1 other identifier: POMMIER J'InvEST-I 2023
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Microvascular Angina

Outcome Measures

Primary Outcomes (1)

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

  At baseline

Study Arms (2)

IMR<25

People without microvascular angina

Biological: Blood sampling; Procedure: Ophthalmological examination; Other: angina severity questionnaire

IMR≥25

People with microvascular angina

Biological: Blood sampling; Procedure: Ophthalmological examination; Other: angina severity questionnaire

Interventions

Blood sampling BIOLOGICAL

2 tubes of 5 mL

IMR<25; IMR≥25

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.

IMR<25; IMR≥25

angina severity questionnaire OTHER

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

IMR<25; IMR≥25

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Pierre GUILLEMINOT

CONTACT

0380293031; pierre.guilleminot@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: November 13, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)