High Cardiovascular Risk PatientsNESTORNCT03551717
Retinal Microvascularization and Cardiovascular Disease
An observational study of High Cardiovascular Risk Patients and Low Cardiovascular Risk Patients, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Cardiovascular Risk Patients, Low Cardiovascular Risk Patients
- What is being tested?
- Optical Coherence Tomography angiography, Fundus and cardiac ultrasound scan
- How many people
- 155 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2018to 19 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: High and low cardiovascular risk patients
Who may be able to join
- 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.
Who cannot join
- Person not affiliated to national health insurance
- Patient refusal
- Minor patient
- Protected patient
- Ophthalmological history (macular vascular or degenerative disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retinal Microvascularization and Cardiovascular Diseases
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.
Read more
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.
- Being tested
- Optical Coherence Tomography angiography, Fundus, cardiac ultrasound scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography angiographyOther
At the inclusion visit for all patients and at M3 only for 50 patients.
FundusOther
At the inclusion visit for all patients and at M3 only for 50 patients.
cardiac ultrasound scanOther
Only for 50 patients, 3 months after the initial cardiovascular event
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Optical Coherence Tomography angiography; Other: Fundus; Other: cardiac ultrasound scan | |
| 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. Receives: Other: Optical Coherence Tomography angiography; Other: Fundus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface of the avascular zone in the central retina
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start14 Mar 2018
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Cardiovascular Risk PatientsStudies 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
- 155 participants (actual)
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
- NCT03551717
- Sponsor's protocol ID
- MEILLON AOI 2017
- Acronym
- NESTOR
- Status last verified
- May 2020
- First submitted
- 29 May 2018
- Last updated
- 27 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Microvascularization and Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT03551717
- Acronym / sponsor ID
- NESTOR / MEILLON AOI 2017
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High cardiovascular risk patients | – | Other: Optical Coherence Tomography angiography, Other: Fundus, Other: cardiac ultrasound scanAdult 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 patients | – | Other: Optical Coherence Tomography angiography, Other: FundusAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High and low cardiovascular risk patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Person not affiliated to national health insurance
- Patient refusal
- Minor patient
- Protected patient
- Ophthalmological history (macular vascular or degenerative disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography angiographyAt the inclusion visit for all patients and at M3 only for 50 patients. | Other | High cardiovascular risk patients, Low cardiovascular risk patients |
| FundusAt the inclusion visit for all patients and at M3 only for 50 patients. | Other | High cardiovascular risk patients, Low cardiovascular risk patients |
| cardiac ultrasound scanOnly for 50 patients, 3 months after the initial cardiovascular event | Other | High cardiovascular risk patients |
Primary outcome
Surface of the avascular zone in the central retina
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Cardiovascular Risk Patients and Low Cardiovascular Risk Patients, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface of the avascular zone in the central retina (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.