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
  Purpose

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


Condition
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Retina Microvascularisation and Cardiovascular Heart Disease Prediction

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: September 2009
Study Completion Date: October 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027988

Locations
Canada, Quebec
Montreal Heart Institute, 5000 Belanger Street
Montreal, Quebec, Canada, HIT IC8
Sponsors and Collaborators
Montreal Heart Institute
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Bernard Thibault, MD Montreal Heart Institute
  More Information

No publications provided

Responsible Party: Bernard Thibault, Cardiologist - Electrophysiologist, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01027988     History of Changes
Other Study ID Numbers: ICM 08-1050
Study First Received: December 7, 2009
Last Updated: October 29, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Montreal Heart Institute:
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014