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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03177486
Other study ID # FrankSyntax
Secondary ID
Status Completed
Phase N/A
First received May 29, 2017
Last updated June 5, 2017
Start date December 1, 2015
Est. completion date November 18, 2016

Study information

Verified date June 2017
Source Shaanxi Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 364
Est. completion date November 18, 2016
Est. primary completion date November 18, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Diagnosis coronary artery disease by coronary angiography

Exclusion Criteria:

- 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

Study Design


Locations

Country Name City State
China Shaanxi Provincial People's Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Shaanxi Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Follow-up MACE MACE is reported in follow-up patients When MACE is reported or up to 1 year after diagnosis of coronary artery disease
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