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Retinal Microvascularization and Cardiovascular Disease (NESTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03551717
Recruitment Status : Terminated (Lack of inclusion)
First Posted : June 11, 2018
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

The main objective of this study is to investigate whether there are links between the blood vessels of the retina as a whole and heart and/or vascular diseases (cardiovascular diseases).

The arteries and veins of the retina are, like the large vessels of the human body (aorta, coronary, cerebral arteries), exposed to the complications of hypertension, diabetes, obesity, dyslipidemia (abnormal blood lipid profile) or tobacco. Several studies have shown that changes in retinal vessels (microvascularization) generally occur several years before damage to large peripheral vessels (macrovascularization). The study of the vessels of the retina is now possible thanks to simple and non-invasive examinations of photographs (not creating any lesion). They allow a painless evaluation of the vessels in the retina.

Ultimately, if this study is conclusive, the patient's cardiovascular risk could be evaluated simply by analysis of the vessels of the retina.

The study is being conducted in the ophthalmology and cardiology departments of Dijon University Hospital. In total, the investigators wish to include approximately 510 patients who present cardiovascular risk factors (255 low risk patients recruited in the ophthalmology department and 255 high risk patients hospitalized in the cardiology department).

All patients participating in the study will be asked to visit the ophthalmology department for a complete examination of the retina.


Condition or disease Intervention/treatment
High Cardiovascular Risk Patients Low Cardiovascular Risk Patients Other: Optical Coherence Tomography angiography Other: Fundus Other: cardiac ultrasound scan

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Study Type : Observational
Actual Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retinal Microvascularization and Cardiovascular Diseases
Actual Study Start Date : March 14, 2018
Actual Primary Completion Date : April 19, 2019
Actual Study Completion Date : April 19, 2019

Group/Cohort Intervention/treatment
High cardiovascular risk patients
Adult patients hospitalized in the Cardiology Department of the University Hospital of Dijon Burgundy for acute coronary syndrome, patients between D1 and D5 of acute coronary syndrome, who can be moved for an ophthalmology consultation where the retinal imaging is done (heart monitoring in the presence of an experienced cardiologist if necessary)
Other: Optical Coherence Tomography angiography
At the inclusion visit for all patients and at M3 only for 50 patients.

Other: Fundus
At the inclusion visit for all patients and at M3 only for 50 patients.

Other: cardiac ultrasound scan
Only for 50 patients, 3 months after the initial cardiovascular event

Low cardiovascular risk patients

Adult patients recruited in the Ophthalmology Department of the University Hospital of Dijon Burgundy following a standard consultation for cataract surgery.

The age balance of the patients included in the two groups will be checked regularly.

Other: Optical Coherence Tomography angiography
At the inclusion visit for all patients and at M3 only for 50 patients.

Other: Fundus
At the inclusion visit for all patients and at M3 only for 50 patients.




Primary Outcome Measures :
  1. Surface of the avascular zone in the central retina [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
High and low cardiovascular risk patients
Criteria

Inclusion Criteria:

  • Person who gave oral consent
  • High cardiovascular risk group: Adult patients hospitalized in the Cardiology Department of the University Hospital of Dijon Burgundy for acute coronary syndrome, patients between D1 and D5 of acute coronary syndrome, who can be moved for an ophthalmology consultation where the retinal imaging is done (heart monitoring in the presence of an experienced cardiologist if necessary)
  • Low cardiovascular risk group: Adult patients over 40 years of age recruited in the Ophthalmology Department of the University Hospital of Dijon Burgundy following a standard consultation for cataract surgery, ocular surface pathologies and optical correction.

Exclusion Criteria:

  • Person not affiliated to national health insurance
  • Patient refusal
  • Minor patient
  • Protected patient
  • Ophthalmological history (macular vascular or degenerative disorders)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551717


Locations
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France
Chu Dijon Bourogne
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03551717    
Other Study ID Numbers: MEILLON AOI 2017
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases