Coronary Artery DiseaseNCT03177486
Frank Score and Coronary Artery Disease
An observational study of Coronary Artery Disease, run by Shaanxi Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 364 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2015to 18 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients receiving coronary angiography
Who may be able to join
- Diagnosis coronary artery disease by coronary angiography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frank Score and Its Guidance Significance of Making Treatment Strategy in Coronary Artery Disease
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.
- Conditions
- Coronary Artery Disease
- Keywords
- Syntax score, Frank sign, Coronary angiography
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Syntax score completed
Syntax score is calculated by two experienced cardiologists according to the results of coronary angiography
Measured: Up to 30 minutes after completion of coronary angiography
Secondary outcomes (1)
Follow-up MACE
MACE is reported in follow-up patients
Measured: When MACE is reported or up to 1 year after diagnosis of coronary artery disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Dec 2015
- Primary completion18 Nov 2016
- Study completion18 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaanxi Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhongwei, Shaanxi Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177486
- Sponsor's protocol ID
- FrankSyntax
- Status last verified
- Jun 2017
- First submitted
- 29 May 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frank Score and Its Guidance Significance of Making Treatment Strategy in Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03177486
- Acronym / sponsor ID
- FrankSyntax
- Conditions
- Coronary Artery Disease
- Keywords
- Syntax score, Frank sign, Coronary angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Shaanxi Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 18 Nov 2016 (actual)
- Study completion
- 18 Nov 2016 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients receiving coronary angiography
Key inclusion criteria (1 listed)
- Diagnosis coronary artery disease by coronary angiography
Key exclusion criteria (7 listed)
- Diagnosis of malignant tumor
- Positive heart transplant history
- Positive CABG history
- Positive PCI history
- Pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Follow-up MACE
Time frame: When MACE is reported or up to 1 year after diagnosis of coronary artery disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shaanxi Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syntax score completed (time frame: Up to 30 minutes after completion of coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.