Retina Microvascularisation and Cardiovascular Heart Disease Prediction

This study has been completed.
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Bernard Thibault, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01027988
First received: December 7, 2009
Last updated: October 29, 2013
Last verified: October 2013

December 7, 2009
October 29, 2013
September 2009
September 2011   (final data collection date for primary outcome 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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01027988 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Correlation with possible cardiovascular event [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
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Retina Microvascularisation and Cardiovascular Heart Disease Prediction
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

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

(50 to 70 years old) with history of coronary heart disease (CHD) or one or more risk factors.

Cardiovascular Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2013
September 2011   (final data collection date for primary outcome measure)

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
Both
50 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01027988
ICM 08-1050
Yes
Bernard Thibault, Montreal Heart Institute
Montreal Heart Institute
Fonds de la Recherche en Santé du Québec
Principal Investigator: Bernard Thibault, MD Montreal Heart Institute
Montreal Heart Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP