Retina Microvascularisation and Cardiovascular Heart Dise... | NCT01027988

Studies
Retina Microvascularisation and Cardiovascular Heart Disease Prediction

NCT01027988

Sponsor

Montreal Heart Institute

Status

Completed

Last Update Posted

Oct 30, 2013Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Cardiovascular Disease

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Oct 2013Actual

First Submitted Date

Dec 7, 2009

First Submission Date that Met QC Criteria

Dec 8, 2009

First Posted Date

Dec 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2013

Last Update Posted Date

Oct 30, 2013Estimated

Name	Class
Fonds de la Recherche en Santé du Québec	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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)
- 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernard Thibault, MD	Montreal Heart Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montreal Heart Institute, 5000 Belanger Street		Montreal	Quebec	HIT IC8	Canada