Retina Microvascularisation and Cardiovascular Heart Disease Prediction

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01027988

Enrollment

Registered

2009-12-09

Start date

2009-09-30

Completion date

2013-10-31

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Retinal Microvascularisation, Fundus, mfERGs, CHF, Cardiovascular Disease, Coronarography, Macrovascularisation, The objectives are to assess if if any retinal vascular disorder in arterioles and venules can be predictive for cardiovascular morbidity and mortality

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

Canada

Outcome results