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.
Verified December 2012 by McGill University Health Center
Sponsor:
McGill University Health Center
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
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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
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 May 23, 2013