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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Nadia Giannetti, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01742156
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition
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)
Groups/Cohorts
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

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742156

Contacts
Contact: Charlene Barber, BScN MBA 514 934 1934 ext 36764 charlene.barber@muhc.mcgill.ca

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

No publications provided

Responsible Party: Nadia Giannetti, Chief of Cardiology, McGill University Health Center
ClinicalTrials.gov 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:
CAD
microangiopathy
patients
more likely
to have tortuosity
of conjunctival vessels

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014