Single Blind Randomized Study to Determine the Sensitivity and Specificity of 2 Non-invasive Markers of Early Coronary Disease

NCT01742156 | Terminated

• 1 other identifier: OPTH-CAD
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Diagonal ear lobe crease and microcirculatory disorder in the conjunctiva are both non invasive methods documented in the literature as early signs of coronary artery disease. We wish to study the sensitivity and specificity of both signs by conducting a single blind study involving patients with documented presence or absence of coronary artery disease via angiogram.

Conditions

Coronary Artery Disease

Keywords

CAD; microangiopathy; patients; more likely; to have tortuosity; of conjunctival vessels

Outcome Measures

Primary Outcomes (1)

• Presence of tortuosity of conjunctival vessels

  1 year

Study Arms (2)

Presence of coronary disease

All patients with or without coronary disease who are followed in coronary clinics or wards

coronary disease

Is coronary disease associated with tortuosity of vessels Patients seen in cardiology clinics

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients (CCU) and Outpatients (CHF clinic, congenital heart clinic) who have had an angiogram within the past 12 weeks documenting the extent of coronary artery disease

You may qualify if:

• age 20 to 70 years old
• angiogram within past 12 weeks
• stable during post angio period
• willing to provide informed consent

You may not qualify if:

• previous eye surgery including cataract surgery
• previous ophthalmologic disorders
• previous surgeries involving ears or ear lobes

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Nadia Giannetti, MD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiology

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 5, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

CA (1)