Cardiovascular DiseasesNCT05082402
Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease
An observational study of Cardiovascular Diseases and Retina; Change, run by Northwestern University at 1 site in United States.
Trial summary
This study aims to determine whether changes in retinal vasculature seen on SS-OCTA can be correlated to degree of cardiovascular disease as measured by carotid duplex ultrasonography. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Retina; Change
- What is being tested?
- Swept Source Optical Coherence Tomography Angiography
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 31 Oct 2023
- 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 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: These subjects were identified in the Northwestern Medicine Division of Vascular Surgery during their standard of care visit.
Who may be able to join
- Subjects between 18 and 95 years of age
- Able to participate in a clinical eye examination setting
- Able to consent
- Subjects receiving standard of care carotid duplex ultrasounds
Who cannot join
- Inability to get high quality imaging for any reason (ex. Dense cataract, media opacity)
- Lack of capacity to provide informed consent
- Subjects younger than 18 years of age or older than 95 years of age
- History of stroke or acute loss of vision
- Unable to participate in a clinical eye examination setting
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University/Northwestern Medical Group, Department of Ophthalmology
Chicago, Illinois, 60611
About this study
This study aims to determine whether changes in retinal vasculature seen on SS-OCTA can be correlated to degree of cardiovascular disease as measured by carotid duplex ultrasonography.
Read the detailed description
The study's primary objective is to determine whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hollenhorst or other plaques, and/or areas of ischemia.
- Conditions
- Cardiovascular Diseases, Retina; Change
- Being tested
- Swept Source Optical Coherence Tomography Angiography
- Keywords
- retinal vasculature, cardiovascular disease, swept source optical coherence tomography angiography, SS-OCTA, carotid duplex ultrasonography
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swept Source Optical Coherence Tomography AngiographyDiagnostic test
The PLEX Elite 9000 is an FDA cleared research device for use in ocular imaging obtained by Northwestern University by way of a purchase agreement with the manufacturer, Carl Zeiss Meditec, Inc. It is currently unavailable outside of participation in the ARI Network, a cloudbased storage and image processing platform using deidentified information shared between academic institutions. The ARI Network is managed by a group of physicians and scientists from around the world that are working to better understand eye diseases.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | 50 participants identified in the Northwestern Medicine Division of Vascular Surgery. Receives: Diagnostic Test: Swept Source Optical Coherence Tomography Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography
Determining whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hellenhorst or other plaques, and/or areas of ischemia.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start17 Aug 2021
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukhsana Mirza, Northwestern University
- Investigators
- Rukhsana Mirza, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082402
- Sponsor's protocol ID
- STU00215189
- Status last verified
- May 2026
- First submitted
- 5 Oct 2021
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Climie RE, van Sloten TT, Bruno RM, Taddei S, Empana JP, Stehouwer CDA, Sharman JE, Boutouyrie P, Laurent S. Macrovasculature and Microvasculature at the Crossroads Between Type 2 Diabetes Mellitus and Hypertension. Hypertension. 2019 Jun;73(6):1138-1149. doi: 10.1161/HYPERTENSIONAHA.118.11769. No abstract available.
PubMed 31067192Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 2008 Nov;88(11):1322-35. doi: 10.2522/ptj.20080008. Epub 2008 Sep 18.
PubMed 18801863Wang SB, Mitchell P, Plant AJ, Phan K, Liew G, Thiagalingam A, Burlutsky G, Gopinath B. Metabolic syndrome and retinal microvascular calibre in a high cardiovascular disease risk cohort. Br J Ophthalmol. 2016 Aug;100(8):1041-6. doi: 10.1136/bjophthalmol-2015-307637. Epub 2015 Nov 3.
PubMed 26531050Zhao Y, Yang K, Wang F, Liang Y, Peng Y, Shen R, Wong T, Wang N. Associations between metabolic syndrome and syndrome components and retinal microvascular signs in a rural Chinese population: the Handan Eye Study. Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1755-63. doi: 10.1007/s00417-012-2109-2. Epub 2012 Sep 5.
PubMed 22948948Michelson EL, Morganroth J, Nichols CW, MacVaugh H 3rd. Retinal arteriolar changes as an indicator of coronary artery disease. Arch Intern Med. 1979 Oct;139(10):1139-41.
PubMed 485746Phan K, Mitchell P, Liew G, Plant AJ, Wang SB, Au C, Chiha J, Kovoor P, Thiagalingam A, Burlutsky G, Gopinath B. Association between Retinal Arteriolar and Venule Calibre with Prevalent Heart Failure: A Cross-Sectional Study. PLoS One. 2015 Dec 11;10(12):e0144850. doi: 10.1371/journal.pone.0144850. eCollection 2015.
PubMed 26659133Wong TY, Cheung N, Islam FM, Klein R, Criqui MH, Cotch MF, Carr JJ, Klein BE, Sharrett AR. Relation of retinopathy to coronary artery calcification: the multi-ethnic study of atherosclerosis. Am J Epidemiol. 2008 Jan 1;167(1):51-8. doi: 10.1093/aje/kwm256. Epub 2007 Sep 24.
PubMed 17893402Liew G, Mitchell P, Chiha J, Plant AJH, White A, Joachim N, Wang S, Burlutsky G, Kovoor P, Thiagalingam A, Gopinath B. Retinal microvascular changes in microvascular angina: Findings from the Australian Heart Eye Study. Microcirculation. 2019 Aug;26(6):e12536. doi: 10.1111/micc.12536. Epub 2019 Mar 20.
PubMed 30758094Liew G, Wang JJ, Mitchell P, Wong TY. Retinal vascular imaging: a new tool in microvascular disease research. Circ Cardiovasc Imaging. 2008 Sep;1(2):156-61. doi: 10.1161/CIRCIMAGING.108.784876.
PubMed 19808533Tabatabaee A, Asharin MR, Dehghan MH, Pourbehi MR, Nasiri-Ahmadabadi M, Assadi M. Retinal vessel abnormalities predict coronary artery diseases. Perfusion. 2013 May;28(3):232-7. doi: 10.1177/0267659112473173. Epub 2013 Jan 15.
PubMed 23322671Wang SB, Mitchell P, Liew G, Wong TY, Phan K, Thiagalingam A, Joachim N, Burlutsky G, Gopinath B. A spectrum of retinal vasculature measures and coronary artery disease. Atherosclerosis. 2018 Jan;268:215-224. doi: 10.1016/j.atherosclerosis.2017.10.008. Epub 2017 Oct 10.
PubMed 29050745Cheung N, Bluemke DA, Klein R, Sharrett AR, Islam FM, Cotch MF, Klein BE, Criqui MH, Wong TY. Retinal arteriolar narrowing and left ventricular remodeling: the multi-ethnic study of atherosclerosis. J Am Coll Cardiol. 2007 Jul 3;50(1):48-55. doi: 10.1016/j.jacc.2007.03.029. Epub 2007 Jun 18.
PubMed 17601545Wang L, Wong TY, Sharrett AR, Klein R, Folsom AR, Jerosch-Herold M. Relationship between retinal arteriolar narrowing and myocardial perfusion: multi-ethnic study of atherosclerosis. Hypertension. 2008 Jan;51(1):119-26. doi: 10.1161/HYPERTENSIONAHA.107.098343. Epub 2007 Nov 12.
PubMed 17998474Murray CSG, Nahar T, Kalashyan H, Becher H, Nanda NC. Ultrasound assessment of carotid arteries: Current concepts, methodologies, diagnostic criteria, and technological advancements. Echocardiography. 2018 Dec;35(12):2079-2091. doi: 10.1111/echo.14197.
PubMed 30506607Kadian-Dodov D, Papolos A, Olin JW. Diagnostic utility of carotid artery duplex ultrasonography in the evaluation of syncope: a good test ordered for the wrong reason. Eur Heart J Cardiovasc Imaging. 2015 Jun;16(6):621-5. doi: 10.1093/ehjci/jeu315. Epub 2015 Feb 10.
PubMed 25669837
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05082402
- Acronym / sponsor ID
- STU00215189
- Conditions
- Cardiovascular Diseases, Retina; Change
- Keywords
- retinal vasculature, cardiovascular disease, swept source optical coherence tomography angiography, SS-OCTA, carotid duplex ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 19 Oct 2021 (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.
This study aims to determine whether changes in retinal vasculature seen on SS-OCTA can be correlated to degree of cardiovascular disease as measured by carotid duplex ultrasonography.
Detailed description
The study's primary objective is to determine whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hollenhorst or other plaques, and/or areas of ischemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Diagnostic Test: Swept Source Optical Coherence Tomography Angiography50 participants identified in the Northwestern Medicine Division of Vascular Surgery. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- These subjects were identified in the Northwestern Medicine Division of Vascular Surgery during their standard of care visit.
Key inclusion criteria (4 listed)
- Subjects between 18 and 95 years of age
- Able to participate in a clinical eye examination setting
- Able to consent
- Subjects receiving standard of care carotid duplex ultrasounds
Key exclusion criteria (5 listed)
- Inability to get high quality imaging for any reason (ex. Dense cataract, media opacity)
- Lack of capacity to provide informed consent
- Subjects younger than 18 years of age or older than 95 years of age
- History of stroke or acute loss of vision
- Unable to participate in a clinical eye examination setting
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 |
|---|---|---|
| Swept Source Optical Coherence Tomography AngiographyThe PLEX Elite 9000 is an FDA cleared research device for use in ocular imaging obtained by Northwestern University by way of a purchase agreement with the manufacturer, Carl Zeiss Meditec, Inc. It is currently unavailable outside of participation in the ARI Network, a cloudbased storage and image processing platform using deidentified information shared between academic institutions. The ARI Network is managed by a group of physicians and scientists from around the world that are working to better understand eye diseases. | Diagnostic test | All Participants |
Primary outcome
Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography
Time frame: 2 hours
Determining whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hellenhorst or other plaques, and/or areas of ischemia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 31067192Climie RE, van Sloten TT, Bruno RM, Taddei S, Empana JP, Stehouwer CDA, Sharman JE, Boutouyrie P, Laurent S. Macrovasculature and Microvasculature at the Crossroads Between Type 2 Diabetes Mellitus and Hypertension. Hypertension. 2019 Jun;73(6):1138-1149. doi: 10.1161/HYPERTENSIONAHA.118.11769. No abstract available.
- Background: PubMed 18801863Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 2008 Nov;88(11):1322-35. doi: 10.2522/ptj.20080008. Epub 2008 Sep 18.
- Background: PubMed 26531050Wang SB, Mitchell P, Plant AJ, Phan K, Liew G, Thiagalingam A, Burlutsky G, Gopinath B. Metabolic syndrome and retinal microvascular calibre in a high cardiovascular disease risk cohort. Br J Ophthalmol. 2016 Aug;100(8):1041-6. doi: 10.1136/bjophthalmol-2015-307637. Epub 2015 Nov 3.
- Background: PubMed 22948948Zhao Y, Yang K, Wang F, Liang Y, Peng Y, Shen R, Wong T, Wang N. Associations between metabolic syndrome and syndrome components and retinal microvascular signs in a rural Chinese population: the Handan Eye Study. Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1755-63. doi: 10.1007/s00417-012-2109-2. Epub 2012 Sep 5.
- Background: PubMed 485746Michelson EL, Morganroth J, Nichols CW, MacVaugh H 3rd. Retinal arteriolar changes as an indicator of coronary artery disease. Arch Intern Med. 1979 Oct;139(10):1139-41.
- Background: PubMed 26659133Phan K, Mitchell P, Liew G, Plant AJ, Wang SB, Au C, Chiha J, Kovoor P, Thiagalingam A, Burlutsky G, Gopinath B. Association between Retinal Arteriolar and Venule Calibre with Prevalent Heart Failure: A Cross-Sectional Study. PLoS One. 2015 Dec 11;10(12):e0144850. doi: 10.1371/journal.pone.0144850. eCollection 2015.
- Background: PubMed 17893402Wong TY, Cheung N, Islam FM, Klein R, Criqui MH, Cotch MF, Carr JJ, Klein BE, Sharrett AR. Relation of retinopathy to coronary artery calcification: the multi-ethnic study of atherosclerosis. Am J Epidemiol. 2008 Jan 1;167(1):51-8. doi: 10.1093/aje/kwm256. Epub 2007 Sep 24.
- Background: PubMed 30758094Liew G, Mitchell P, Chiha J, Plant AJH, White A, Joachim N, Wang S, Burlutsky G, Kovoor P, Thiagalingam A, Gopinath B. Retinal microvascular changes in microvascular angina: Findings from the Australian Heart Eye Study. Microcirculation. 2019 Aug;26(6):e12536. doi: 10.1111/micc.12536. Epub 2019 Mar 20.
- Background: PubMed 19808533Liew G, Wang JJ, Mitchell P, Wong TY. Retinal vascular imaging: a new tool in microvascular disease research. Circ Cardiovasc Imaging. 2008 Sep;1(2):156-61. doi: 10.1161/CIRCIMAGING.108.784876.
- Background: PubMed 23322671Tabatabaee A, Asharin MR, Dehghan MH, Pourbehi MR, Nasiri-Ahmadabadi M, Assadi M. Retinal vessel abnormalities predict coronary artery diseases. Perfusion. 2013 May;28(3):232-7. doi: 10.1177/0267659112473173. Epub 2013 Jan 15.
- Background: PubMed 29050745Wang SB, Mitchell P, Liew G, Wong TY, Phan K, Thiagalingam A, Joachim N, Burlutsky G, Gopinath B. A spectrum of retinal vasculature measures and coronary artery disease. Atherosclerosis. 2018 Jan;268:215-224. doi: 10.1016/j.atherosclerosis.2017.10.008. Epub 2017 Oct 10.
- Background: PubMed 17601545Cheung N, Bluemke DA, Klein R, Sharrett AR, Islam FM, Cotch MF, Klein BE, Criqui MH, Wong TY. Retinal arteriolar narrowing and left ventricular remodeling: the multi-ethnic study of atherosclerosis. J Am Coll Cardiol. 2007 Jul 3;50(1):48-55. doi: 10.1016/j.jacc.2007.03.029. Epub 2007 Jun 18.
- Individual participant dataSharing planned: No
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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.
Rukhsana Mirza, MD principal investigator
Northwestern University
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 Cardiovascular Diseases and Retina; Change, run by Northwestern University at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 22 May 2026. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05082402, which also lists 20 linked publications.
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 22 May 2026.