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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute, 5000 Belanger Street

Montreal, Quebec, HIT IC8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 2 years

Secondary outcomes

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

Time frame: 2 years
Correlation with possible cardiovascular event

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

Fonds de la Recherche en Santé du Québec

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2013
First posted: Dec 9, 2009
Registry last updated: Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed