Retina Microvascularisation and Cardiovascular Heart Disease Prediction

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT01027988
• Lead Sponsor: Montreal Heart Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2011-09
• Status Verified: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Montreal Heart Institute, 5000 Belanger Street; 🇨🇦 Montreal, Quebec, Canada