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

This study has been terminated.
(inadequate number of recruita)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01742156
First Posted: December 5, 2012
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nadia Giannetti, McGill University Health Center
  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 Nadia Giannetti, McGill University Health Center:

Primary Outcome Measures:
  • Presence of tortuosity of conjunctival vessels [ Time Frame: 1 year ]

Enrollment: 10
Study Start Date: January 2013
Study Completion Date: September 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742156


Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Nadia Giannetti, MD McGill University
  More Information

Responsible Party: Nadia Giannetti, Chief of Cardiology, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01742156     History of Changes
Other Study ID Numbers: OPTH-CAD
First Submitted: December 3, 2012
First Posted: December 5, 2012
Last Update Posted: April 7, 2017
Last Verified: April 2017

Keywords provided by Nadia Giannetti, 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