Single Blind Randomized Study to Determine the Sensitivit... | NCT01742156

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inadequate number of recruita

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Dec 3, 2012

First Submission Date that Met QC Criteria

Dec 4, 2012

First Posted Date

Dec 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2017

Last Update Posted Date

Apr 7, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nadia Giannetti, Chief of Cardiology, McGill University Health Centre/Research Institute of the McGill University Health CentrePrincipal Investigator

Lead Sponsor

McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 or absence of coronary artery disease via angiogram.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Measure	Description	Time Frame
Presence of tortuosity of conjunctival vessels		1 year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nadia Giannetti, MD	McGill University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Victoria Hospital		Montreal	Quebec	H3A 1A1	Canada

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases