Evaluation of the Capacity of a Camera to Identify Signs of Arteriosclerosis in Retinal Arterioles

NCT02849405 | Completed

• 1 other identifier: ICM-ART-P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Arteriosclerosis is a degenerative and dysmetabolic disease of the arterial walls. It is known to be the principal cause of coronary artery disease (CAD). Arteriosclerosis has an impact on the entire vascularization including the microvascularization. The retina is a nervous tissue that is supported by microvascularization. Therefore, systemic diseases that affect the nervous or the cardiovascular system are susceptible to have manifestations in the retina. Retinal signs associated to the risks to develop CAD (qualitative appreciation; diameter and appearance of arterioles) have been suggested. A quantitative approach would strengthen the interpretation of these evaluations. The Metabolic Hyperspectral Retinal Camera (MHRC) - the experimental instrument - has the capacity to identify and quantify a variety of biomolecules specific to the retina and the optic nerve. The purpose of this pilot study is to determine if the MHRC has the capacity to detect a specific hyperspectral signature in the retinal arterioles of subjects suffering from arteriosclerosis.

Conditions

Arteriosclerosis

Outcome Measures

Primary Outcomes (1)

• Spectral intensity measures to visible and near infrared light around retinal arterioles in 30 patients with clearly defined atherosclerosis and 30 controls.

  Data will be aggregated for all arterioles identified in retinal image to produce a single outcome

  1 Year

Study Arms (2)

Arteriosclerosis

OTHER

Hyperspectral camera for arteriosclerosis Diagnostic

Device: MHRC: Metabolic Hyperspectral Retinal Camera

Healthy controls

OTHER

Hyperspectral camera for healthy control Diagnostic

Device: MHRC: Metabolic Hyperspectral Retinal Camera

Interventions

MHRC: Metabolic Hyperspectral Retinal Camera DEVICE

Comparison of hyperspectral signature of retinal arterioles between subjects suffering from arteriosclerosis and healthy control subjects.

Arteriosclerosis; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects suffering from arteriosclerosis:
• myocardial infarction
• coronary angiography showing at least one coronary stenosis (more than 50%)
• and/or coronary angioplasty
• and/or coronary bypass.
• Healthy control subjects:
• absence of a medical history of cardiovascular disease
• absence of medical history of cerebrovascular disease
• absence of a medical history of peripheral arterial disease

You may not qualify if:

• Healthy control subjects:
• myocardial infarction or angina
• known coronary stenosis
• coronary angioplasty history or coronary bypass surgery
• stroke or transient ischemic attack history
• peripheral arterial disease history
• active smoking or history smoking in the past 5 years
• diabetes mellitus
• familial hypercholesterolemia
• poorly controlled hypertension (systolic blood pressure ≥150 mm Hg)
• All subjects:
• medium or high opacity of the lens (which interferes with the MHRC imaging)
• bleeding in the vitreous (which interfere with MHRC imaging)
• presence of venous occlusion, age-related macular degeneration or glaucoma
• pupillary dilation inadequate or contra-indicated

Sponsors & Collaborators

• Jean-Claude Tardif: lead
• Montreal Heart Institute: collaborator
• Polytechnique Montréal: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (11)

• Delori FC, Webb RH, Sliney DH; American National Standards Institute. Maximum permissible exposures for ocular safety (ANSI 2000), with emphasis on ophthalmic devices. J Opt Soc Am A Opt Image Sci Vis. 2007 May;24(5):1250-65. doi: 10.1364/josaa.24.001250.

  PMID: 17429471 BACKGROUND

• Sliney D, Aron-Rosa D, DeLori F, Fankhauser F, Landry R, Mainster M, Marshall J, Rassow B, Stuck B, Trokel S, West TM, Wolffe M; International Commission on Non-Ionizing Radiation Protection. Adjustment of guidelines for exposure of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Non-Ionizing Radiation Protection (ICNIRP). Appl Opt. 2005 Apr 10;44(11):2162-76. doi: 10.1364/ao.44.002162.

  PMID: 15835362 BACKGROUND

• Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med. 2005 Apr 21;352(16):1685-95. doi: 10.1056/NEJMra043430. No abstract available.

  PMID: 15843671 BACKGROUND

• Abramoff MD, Garvin MK, Sonka M. Retinal imaging and image analysis. IEEE Rev Biomed Eng. 2010;3:169-208. doi: 10.1109/RBME.2010.2084567.

  PMID: 22275207 BACKGROUND

• Tabatabaee 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.

  PMID: 23322671 BACKGROUND

• Wong TY, Klein R, Sharrett AR, Duncan BB, Couper DJ, Tielsch JM, Klein BE, Hubbard LD. Retinal arteriolar narrowing and risk of coronary heart disease in men and women. The Atherosclerosis Risk in Communities Study. JAMA. 2002 Mar 6;287(9):1153-9. doi: 10.1001/jama.287.9.1153.

  PMID: 11879113 BACKGROUND

• Patel SR, Flanagan JG, Shahidi AM, Sylvestre JP, Hudson C. A prototype hyperspectral system with a tunable laser source for retinal vessel imaging. Invest Ophthalmol Vis Sci. 2013 Aug 1;54(8):5163-8. doi: 10.1167/iovs.13-12124.

  PMID: 23821191 BACKGROUND

• Shahidi AM, Patel SR, Flanagan JG, Hudson C. Regional variation in human retinal vessel oxygen saturation. Exp Eye Res. 2013 Aug;113:143-7. doi: 10.1016/j.exer.2013.06.001. Epub 2013 Jun 18.

  PMID: 23791637 BACKGROUND

• Kang MH, Balaratnasingam C, Yu PK, Morgan WH, McAllister IL, Cringle SJ, Yu DY. Alterations to vascular endothelium in the optic nerve head in patients with vascular comorbidities. Exp Eye Res. 2013 Jun;111:50-60. doi: 10.1016/j.exer.2013.03.005. Epub 2013 Mar 19.

  PMID: 23518407 BACKGROUND

• Koc S, Ozin B, Altin C, Altan Yaycioglu R, Aydinalp A, Muderrisoglu H. Evaluation of circulation disorder in coronary slow flow by fundus fluorescein angiography. Am J Cardiol. 2013 Jun 1;111(11):1552-6. doi: 10.1016/j.amjcard.2013.01.324. Epub 2013 Mar 25.

  PMID: 23538021 BACKGROUND

• Sayin N, Kara N, Uzun F, Akturk IF. A quantitative evaluation of the posterior segment of the eye using spectral-domain optical coherence tomography in carotid artery stenosis: a pilot study. Ophthalmic Surg Lasers Imaging Retina. 2015 Feb;46(2):180-5. doi: 10.3928/23258160-20150213-20.

  PMID: 25707042 BACKGROUND

MeSH Terms

Conditions

Arteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean-Claude Tardif, MD

  Montreal Heart Insitute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Research Center

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 29, 2016
• Study Start: December 21, 2016
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)