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Recruiting NCT06692751

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).

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Clinical Trial Summary
NCT ID NCT06692751
Status Recruiting
Phase
Sponsor Centre Hospitalier Universitaire Dijon
Condition Microvascular Angina
Study Type OBSERVATIONAL
Enrollment 158 participants
Start Date 2024-11-13
Primary Completion 2027-11

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Blood samplingOphthalmological examinationangina severity questionnaire

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 158 participants in total. It began in 2024-11-13 with a primary completion date of 2027-11.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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)

Contact & Investigator

Central Contact

Pierre GUILLEMINOT

✉ pierre.guilleminot@chu-dijon.fr

📞 0380293031

Frequently Asked Questions

Who can join the NCT06692751 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Microvascular Angina. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06692751 currently recruiting?

Yes, NCT06692751 is actively recruiting participants. Contact the research team at pierre.guilleminot@chu-dijon.fr for enrollment information.

Where is the NCT06692751 trial being conducted?

This trial is being conducted at Dijon, France.

Who is sponsoring the NCT06692751 clinical trial?

NCT06692751 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 158 participants.

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