Retina Microvascularisation and Cardiovascular Heart Disease Prediction

Earlier studies have found that retinal photography could be very useful for evaluating the condition of microcirculation and the risk of cardiovascular diseases in patients. The architectural changes in retinal vascularisation strongly correlates with macrovascular remodeling. Also, recent founding suggests a possible close anatomical parallel between both the macrovascular and the microvascular blood.

Our objectives are to assess (1) in which age and sex subgroups, if any, retinal vascular alteration in arterioles and venules can be predictive for cardiovascular morbidity and mortality; and (2) whether variations in arteriolar or venular caliber will predict better cardiovascular pathogenesis in normal and patient population. If the association between the diameter of the retinal vessels and the risks of cardiovascular disease is verified during this study, the impact on prevention would be enormous. The retinal microvascular change could become a powerful biomarker in the early detection of the cardiovascular pathogenesis and death risk

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, HIT IC8
      • Montreal Heart Institute, 5000 Belanger Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

(50 to 70 years old) with history of coronary heart disease (CHD) or one or more risk factors.

Description

Inclusion Criteria:

• Age between 50 to 70 years old (male/female)
• indication of coronarography within the last 3 month preceding the enrollment
• Patients with history of stroke, heart failure or arteriosclerosis.

• At least one of the following risk factors for cardiovascular complication:

  • Hypertension
  • Coronary heart disease (CHD)
  • Diabetes
  • Structural heart disease
  • Dyslipidemia
  • Obesity

Exclusion Criteria:

• Patients with a permanent pacemaker or ICD
• Nephrosis or chronic renal failure
• The study interferes with therapeutic or diagnostic procedures
• Patients with inability to consent or comply with follow up requirements
• Patients with glaucoma
• Patients with any retina degeneration disease vascular age-related macular degeneration or any -retina degeneration disease
• Patients who are pregnant

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of a major cardiovascular event or complication, defined as hospitalization, death from coronary heart disease, hypertension, arteriosclerosis, nonfatal non-procedure-related myocardial infarction, or fatal or nonfatal stroke	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterization of any retinal vascular disorders occurring at any time during the study: i. Confirmed by an ophthalmologist examination and either an fundus camera or an mfERGs examination ii. Occurrence of serious ophthalmic event	2 years
Correlation with possible cardiovascular event	2 years

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Collaborators: Fonds de la Recherche en Santé du Québec
• Investigators: Principal Investigator: Bernard Thibault, MD, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; CHF; Fundus; Coronarography; Retinal Microvascularisation; mfERGs; Macrovascularisation; The objectives are to assess if if any retinal vascular disorder in arterioles and venules can be predictive for cardiovascular morbidity and mortality
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases
• Other Study ID Numbers: ICM 08-1050