Retina Microvascularisation and Cardiovascular Heart Disease Prediction

Cardiovascular Disease Clinical Trial

Official title:

Retina Microvascularisation and Cardiovascular Heart Disease Prediction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027988
• Other study ID #: ICM 08-1050
• Status: Completed
• Phase: N/A
• First received: December 7, 2009
• Last updated: October 29, 2013
• Start date: September 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Heart Diseases

Locations

Country	Name	City	State
Canada	Montreal Heart Institute, 5000 Belanger Street	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Correlation with possible cardiovascular event		2 years	Yes