Coronary Artery DiseaseREFERRALNCT04068779
Long-term Clinical Outcomes in Patients With FFR Guided-Deferred Coronary Lesions, Assessed by IVUS Analysis
An observational study of Coronary Artery Disease, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
This study was a multicenter retrospective study that included intravascular ultrasound (IVUS) in patients with delayed stent insertion based on fractional flow reserve (FFR) in moderately narrowed coronary lesions. We would like to see the effect of lesion characteristics on clinical course. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 459 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2019to 31 May 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.
Who may be able to join
- Subject over 19 years old
- Patients with mild or moderate stenosis lesions on coronary angiography
- Patients with lesions with FFR values greater than 0.80
- Patients with analytical intravascular ultrasound images
Who cannot join
- Left main lesion
- History of coronary artery bypass grafting
- Patients with lower left ventricular ejection fraction (<25%)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Clinical Outcomes in Patients With FFR GuidEd-DeFERred CoRonAry Lesions, Assessed by IVUS Analysis
This study was a multicenter retrospective study that included intravascular ultrasound (IVUS) in patients with delayed stent insertion based on fractional flow reserve (FFR) in moderately narrowed coronary lesions. We would like to see the effect of lesion characteristics on clinical course.
Read the detailed description
From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.
- Target patient screening The database will select patients who meet the selection and exclusion criteria.
- target patient characteristics The age, sex, smoking status, medical history (hypertension, diabetes mellitus, hyperlipidemia), diagnosis, and left ventricular blood count measured by echocardiography should be checked through a computerized medical record.
- coronary angiography Coronary angiography images of the subjects in the blinded state are analyzed to investigate the length of lesions, reference vessel diameter, and minimal vessel diameter.
- intravascular ultrasound In the blinded state, the vessel's vessel area, plaque area, lumen area, etc. are measured by analyzing intravascular ultrasound images of the patient using EchoPlaque (Indec Systems, Mountain View, CA).
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-oriented composite outcome
all-cause death, myocardial infarction and any revascularization
Measured: during 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start31 May 2019
- Primary completion31 May 2020
- Study completion31 May 2020
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-kyeong Cho, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068779
- Sponsor's protocol ID
- 2019-05-048
- Acronym
- REFERRAL
- Status last verified
- Feb 2020
- First submitted
- 23 Aug 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Clinical Outcomes in Patients With FFR GuidEd-DeFERred CoRonAry Lesions, Assessed by IVUS Analysis
- ClinicalTrials.gov ID
- NCT04068779
- Acronym / sponsor ID
- REFERRAL / 2019-05-048
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 28 Aug 2019 (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.
This study was a multicenter retrospective study that included intravascular ultrasound (IVUS) in patients with delayed stent insertion based on fractional flow reserve (FFR) in moderately narrowed coronary lesions. We would like to see the effect of lesion characteristics on clinical course.
Detailed description
From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.
- Target patient screening The database will select patients who meet the selection and exclusion criteria.
- target patient characteristics The age, sex, smoking status, medical history (hypertension, diabetes mellitus, hyperlipidemia), diagnosis, and left ventricular blood count measured by echocardiography should be checked through a computerized medical record.
- coronary angiography Coronary angiography images of the subjects in the blinded state are analyzed to investigate the length of lesions, reference vessel diameter, and minimal vessel diameter.
- intravascular ultrasound In the blinded state, the vessel's vessel area, plaque area, lumen area, etc. are measured by analyzing intravascular ultrasound images of the patient using EchoPlaque (Indec Systems, Mountain View, CA).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2007 to August 2014, patients who meet the criteria for selection and exclusion from Keimyung University Dongsan Hospital, Seoul National University Hospital, Inje University Busan Paik Hospital, and Ulsan University Hospital are included.
Key inclusion criteria (4 listed)
- Subject over 19 years old
- Patients with mild or moderate stenosis lesions on coronary angiography
- Patients with lesions with FFR values greater than 0.80
- Patients with analytical intravascular ultrasound images
Key exclusion criteria (3 listed)
- Left main lesion
- History of coronary artery bypass grafting
- Patients with lower left ventricular ejection fraction (<25%)
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
patient-oriented composite outcome
Time frame: during 5-year
all-cause death, myocardial infarction and any revascularization
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 2 Sep 2020.
- Individual participant dataSharing planned: No
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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 Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 4 inclusion and 3 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 2 Sep 2020. 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 South Korea. 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?
patient-oriented composite outcome (time frame: during 5-year). 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 2 Sep 2020.