Coronary Artery DiseaseIVUS-CAMSNCT02845505
Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion
An observational study of Coronary Artery Disease, run by Asan Medical Center at 12 sites in South Korea.
Trial summary
The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the IVUS information about myocardial territory… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intravascular Ultrasound, coronary computed tomography angiography
- How many people
- 500 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 22 Aug 2016to 30 Jun 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS assessment prior to intervention will be enrolled. The patients should have at least one coronary artery lesion (including non-left main and isolated left main disease) with visually estimated diameter stenosis >50%
Who may be able to join
- Age 20years or older
- Patients who have at least one epicardial coronary artery lesion (including isolated left main disease or side branch) with visually estimated diameter stenosis >50% and take coronary angiography, CT angiography and IVUS
- Willing and able to provide informed written consent
Who cannot join
- In-stent restenosis
- Bypass graft
- Suspected coronary spasm even after sufficient nitrate injected
- Cases in which the IVUS imaging catheter failed to cross the lesion
- Poor quality IVUS or CT images
- Visible collateral flow on angiography
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Hallym University Sacred Heart hospital
Anyang
Chungnam National University Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do
Inje university Pusan Paik hospital
Pusan
Kosin University Gospel Hospital
Pusan
Pusan National University Hospital
Pusan
Asan Medical Center
Seoul, Songpa-Gu
Kangbuk Samsung Hospital
Seoul
Veterans Hospital Medical Center
Seoul
Ulsan University Hospital
Ulsan
Pusan National University Yangsan Hospital
Yangsan
About this study
The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the IVUS information about myocardial territory and stenosis severity and predicts the extent of CAMS-derived myocardial size.
- Conditions
- Coronary Artery Disease
- Being tested
- Intravascular Ultrasound, coronary computed tomography angiography
- Keywords
- intravascular ultrasonography, Computed Tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular Ultrasound, coronary computed tomography angiographyOther
| Study group | Role | What they receive |
|---|---|---|
| IVUS-CAMS | patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS Receives: Other: Intravascular Ultrasound, coronary computed tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment
Measured: 1 year
Secondary outcomes (2)
Impact of plaque characteristics (attenuated plaque, plaque rupture, calcification, thrombosis, etc.) assessed by IVUS on the ischemic burden assessed by CAMS
Measured: 1 year
Incidence of MACE comprising death, nonfatal myocardial infarction or target vessel revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start22 Aug 2016
- Primary completion22 Apr 2022
- Study completion30 Jun 2026 (estimated)
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.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Young-Hak Kim, MD, PhD, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845505
- Sponsor's protocol ID
- AMCCV 2016-06
- Acronym
- IVUS-CAMS
- Status last verified
- Dec 2023
- First submitted
- 13 Jul 2016
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion
- ClinicalTrials.gov ID
- NCT02845505
- Acronym / sponsor ID
- IVUS-CAMS / AMCCV 2016-06
- Conditions
- Coronary Artery Disease
- Keywords
- intravascular ultrasonography, Computed Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- 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.
The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the IVUS information about myocardial territory and stenosis severity and predicts the extent of CAMS-derived myocardial size.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVUS-CAMS | – | Other: Intravascular Ultrasound, coronary computed tomography angiographypatients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS assessment prior to intervention will be enrolled. The patients should have at least one coronary artery lesion (including non-left main and isolated left main disease) with visually estimated diameter stenosis >50%
Key inclusion criteria (3 listed)
- Age 20years or older
- Patients who have at least one epicardial coronary artery lesion (including isolated left main disease or side branch) with visually estimated diameter stenosis >50% and take coronary angiography, CT angiography and IVUS
- Willing and able to provide informed written consent
Key exclusion criteria (6 listed)
- In-stent restenosis
- Bypass graft
- Suspected coronary spasm even after sufficient nitrate injected
- Cases in which the IVUS imaging catheter failed to cross the lesion
- Poor quality IVUS or CT images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular Ultrasound, coronary computed tomography angiography | Other | IVUS-CAMS |
Primary outcome
mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment
Time frame: 1 year
2 secondary outcomes
Impact of plaque characteristics (attenuated plaque, plaque rupture, calcification, thrombosis, etc.) assessed by IVUS on the ischemic burden assessed by CAMS
Time frame: 1 year
Incidence of MACE comprising death, nonfatal myocardial infarction or target vessel revascularization
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- 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.
12 sites 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 Asan Medical Center at 12 sites 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
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?
mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment (time frame: 1 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 9 Apr 2025.