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Clinical Trials/NCT01027988
NCT01027988
Completed
Not Applicable

Retina Microvascularisation and Cardiovascular Heart Disease Prediction

Montreal Heart Institute1 site in 1 country40 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
Montreal Heart Institute
Enrollment
40
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
October 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Montreal Heart Institute
Responsible Party
Principal Investigator
Principal Investigator

Bernard Thibault

Cardiologist - Electrophysiologist

Montreal Heart Institute

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)
  • Structural heart disease
  • Dyslipidemia

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

Outcomes

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(2 years)
  • Correlation with possible cardiovascular event(2 years)

Study Sites (1)

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