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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by McGill University Health Center.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Nadia Giannetti, McGill University Health Center Identifier:
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: December 2012
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.

Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Presence of tortuosity of conjunctival vessels [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

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

Exclusion Criteria:

  • previous eye surgery including cataract surgery
  • previous ophthalmologic disorders
  • previous surgeries involving ears or ear lobes
  Contacts and Locations
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Please refer to this study by its identifier: NCT01742156

Contact: Charlene Barber, BScN MBA 514 934 1934 ext 36764

Canada, Quebec
Royal Victoria Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Charlene Barber, BScN MBA    514 934 1934 ext 36764   
Principal Investigator: Nadia Giannetti, MD         
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Nadia Giannetti, MD McGill University
  More Information

No publications provided

Responsible Party: Nadia Giannetti, Chief of Cardiology, McGill University Health Center Identifier: NCT01742156     History of Changes
Other Study ID Numbers: OPTH-CAD 
Study First Received: December 3, 2012
Last Updated: December 4, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
more likely
to have tortuosity
of conjunctival vessels

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on February 08, 2016