Coronary Artery DiseaseNCT01742156
Single Blind Randomized Study to Determine the Sensitivity and Specificity of 2 Non-invasive Markers of Early Coronary Disease
An observational study of Coronary Artery Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- age 20 to 70 years old
- angiogram within past 12 weeks
- stable during post angio period
- willing to provide informed consent
Who cannot join
- previous eye surgery including cataract surgery
- previous ophthalmologic disorders
- previous surgeries involving ears or ear lobes
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of tortuosity of conjunctival vessels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionSep 2013
Why it stopped: inadequate number of recruita
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Giannetti, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Nadia Giannetti, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742156
- Sponsor's protocol ID
- OPTH-CAD
- Status last verified
- Apr 2017
- First submitted
- 3 Dec 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind Randomized Study to Determine the Sensitivity and Specificity of 2 Non-invasive Markers of Early Coronary Disease
- ClinicalTrials.gov ID
- NCT01742156
- Acronym / sponsor ID
- OPTH-CAD
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, microangiopathy, patients, more likely, to have tortuosity, of conjunctival vessels
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inadequate number of recruita
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- age 20 to 70 years old
- angiogram within past 12 weeks
- stable during post angio period
- willing to provide informed consent
Key exclusion criteria (3 listed)
- previous eye surgery including cataract surgery
- previous ophthalmologic disorders
- previous surgeries involving ears or ear lobes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of tortuosity of conjunctival vessels
Time frame: 1 year
Results and safety
The study was stopped early (reason given: inadequate number of recruita). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Giannetti, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inadequate number of recruita). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of tortuosity of conjunctival vessels (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.