NCT03177486

Brief Summary

Patients with coronary artery disease (CAD) were enrolled. CAD was diagnosed by coronary angiography which also resulted Syntax score. Images of left and right ears were captured by a digital camera. Frank score of each patients was calculated based on characteristics and numbers of wrinkles of the earlobes. Statistic analysis were carried out to analyze the correlation between Frank Score and Syntax Score.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

May 29, 2017

Last Update Submit

June 5, 2017

Conditions

Coronary Artery Disease

Keywords

Syntax scoreFrank signCoronary angiography

Outcome Measures

Primary Outcomes (1)

  • Syntax score completed

    Syntax score is calculated by two experienced cardiologists according to the results of coronary angiography

    Up to 30 minutes after completion of coronary angiography

Secondary Outcomes (1)

  • Follow-up MACE

    When MACE is reported or up to 1 year after diagnosis of coronary artery disease

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients receiving coronary angiography

You may qualify if:

  • Diagnosis coronary artery disease by coronary angiography

You may not qualify if:

  • Diagnosis of malignant tumor
  • Positive heart transplant history
  • Positive CABG history
  • Positive PCI history
  • Pregnant and lactating women
  • Diagnosis of chronic kidney disease
  • Any external ear trauma or disease history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 6, 2017

Study Start

December 1, 2015

Primary Completion

November 18, 2016

Study Completion

November 18, 2016

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

CN(1)