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Frank Score and Coronary Artery Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177486
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Liu Zhongwei, Shaanxi Provincial People's Hospital
  Purpose
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.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: Frank Score and Its Guidance Significance of Making Treatment Strategy in Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Liu Zhongwei, Shaanxi Provincial People's Hospital:

Primary Outcome Measures:
  • Syntax score completed [ Time Frame: Up to 30 minutes after completion of coronary angiography ]
    Syntax score is calculated by two experienced cardiologists according to the results of coronary angiography


Secondary Outcome Measures:
  • Follow-up MACE [ Time Frame: When MACE is reported or up to 1 year after diagnosis of coronary artery disease ]
    MACE is reported in follow-up patients


Enrollment: 364
Actual Study Start Date: December 1, 2015
Study Completion Date: November 18, 2016
Primary Completion Date: November 18, 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients receiving coronary angiography
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177486


Locations
China, Shaanxi
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
Sponsors and Collaborators
Shaanxi Provincial People's Hospital
  More Information

Responsible Party: Liu Zhongwei, Attending doctor, Shaanxi Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03177486     History of Changes
Other Study ID Numbers: FrankSyntax
First Submitted: May 29, 2017
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Liu Zhongwei, Shaanxi Provincial People's Hospital:
Syntax score
Frank sign
Coronary angiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases