Clinical trial NCT01027988: Retina Microvascularisation and Cardiovascular Heart Disease Prediction
Official title: Retina Microvascularisation and Cardiovascular Heart Disease Prediction
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2009-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (50 to 70 years old) with history of coronary heart disease (CHD) or one or more risk factors.

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
measure: Correlation with possible cardiovascular event
timeFrame: 2 years
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute, 5000 Belanger Street
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Bernard Thibault, MD
role: PRINCIPAL_INVESTIGATOR
References: