Frank Score and Coronary Artery Disease | NCT03177486

Studies
Frank Score and Coronary Artery Disease

NCT03177486

Sponsor

Shaanxi Provincial People's Hospital

Status

Completed

Last Update Posted

Jun 6, 2017Actual

Enrollment

364Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2015Actual

Primary Completion Date

Nov 18, 2016Actual

Completion Date

Nov 18, 2016Actual

First Submitted Date

May 29, 2017

First Submission Date that Met QC Criteria

Jun 5, 2017

First Posted Date

Jun 6, 2017Actual

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

Jun 5, 2017

Last Update Posted Date

Jun 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liu Zhongwei, Attending doctor, Shaanxi Provincial People's HospitalPrincipal Investigator

Lead Sponsor

Shaanxi Provincial People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

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

364Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Hospitalized patients receiving coronary angiography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaanxi Provincial People's Hospital		Xi'an	Shaanxi	710068	China

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided