Retina Microvascularisation and Cardiovascular Heart Disease Prediction

NCT01027988 | Completed DMC

• 1 other identifier: ICM 08-1050
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Montreal Heart Institute, 5000 Belanger Street

Montreal, Quebec, HIT IC8, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Bernard Thibault, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist - Electrophysiologist

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2013
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

CA (1)