Stable AnginaNCT03935542
Assessment of Diagonal Branch Territory
An observational study of Stable Angina and Unstable Angina, run by Bon-Kwon Koo at 1 site in South Korea.
Trial summary
This study was performed to investigate the anatomical attributes that determine myocardial territory of diagonal branches and to develop a prediction model for clinically relevant branches using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina
- How many people
- 355 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2015to 8 Oct 2018
- 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 with angina pectoris
Who may be able to join
- Patients with severe jailed diagonal branch disease with available MPI in 3 months (MPI arm)
- Patients who had available FMM value of diagonal branches from a previous multicenter prospective CCTA registry (CCTA arm)
Who cannot join
- Patients with >50% stenosis at left anterior descending coronary artery (LAD) or left circumflex artery (LCx), regional wall motion abnormality at LAD territory (MPI arm)
- Patients with diffuse diagonal branch disease (CCTA arm)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomical Attributes of Clinically Relevant Diagonal Branches in Patients With Left Anterior Descending Coronary Artery Bifurcation Lesions
This study was performed to investigate the anatomical attributes that determine myocardial territory of diagonal branches and to develop a prediction model for clinically relevant branches using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).
Read the detailed description
Bifurcation lesion is one of the most challenging lesion subsets in the field of percutaneous coronary intervention (PCI). Despite the recent advances in PCI techniques and stent technology, most randomized studies failed to prove the superiority of systematic 2 stenting strategy compared with provisional side branch intervention strategy.
A certain amount of ischemic burden is required to achieve the benefit of revascularization over medical treatment. Compared with major epicardial vessels, side branches are smaller, more variable in anatomy, supplying less myocardium and less clinically relevant. Therefore, it is important to assess the myocardial mass at risk of side branches to determine the appropriate treatment strategy for bifurcation lesions. However, how to define the clinically relevant side branches which can be associated with the benefit of revascularization in a cardiac catheterization laboratory is not well-known.
The investigators performed this study to investigate the anatomical attributes that determine ischemic burden and myocardial territory of diagonal branches and to develop a prediction model for a clinically relevant diagonal branch using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).
- Conditions
- Stable Angina, Unstable Angina
- Keywords
- Bifurcation, Side branch, Ischemia, Myocardium, Revascularization
- Medical subject headings
- Angina, Stable, Angina, Unstable, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MPI arm | For the MPI arm, patients with severe jailed diagonal branch disease with available MPI in 3 months were selected from the Seoul National University Hospital Cardiac Catheterization and MPI database. | |
| CCTA arm | For the CCTA arm, patients from a previous multicenter prospective CCTA registry were retrospectively reviewed for a post-hoc analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic attributes for diagonal branches
Angiographic attributes for diagonal branches were visually defined as follows :
- Size was a binary attribute of vessel diameter ≥ 2.5mm or < 2.5mm.
- Number was counted as one, two, and 3 or more diagonal branches.
- Dominancy in patients with 2 diagonal branches (D1/2 dominancy) was a binary attribute for one of two diagonal branches whose diameter was more than two times larger than its smaller counterpart.
- LCx dominancy was defined as a left-dominant system or a presence of obtuse marginal branch originating within proximal 1/3 of LCx and crossing LAD at right anterior oblique caudal view.
Measured: through study completion, an average of 1year
Sensitivity of prediction model
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Measured: through study completion, an average of 1year
Specificity of prediction model
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Measured: through study completion, an average of 1year
Negative predictive value of prediction model
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Measured: through study completion, an average of 1year
Positive predictive value of prediction model
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Measured: through study completion, an average of 1year
Area under the curve of prediction model
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Measured: through study completion, an average of 1year
Accuracy of prediction model
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Measured: through study completion, an average of 1year
Secondary outcomes (2)
%Ischemia
Myocardium of perfusion image was divided into 20 segments, and summed rest score (SRS), summed stress score (SSS), and summed difference score (SDS) were scored in each segment according to a 5-grade system (0-4) for the assessment of perfusion status. (1) SSS and SDS of diagonal segments were converted to percent of myocardial ischemia (%ischemia) of diagonal territory by dividing summed scores by 80 and multiplying by 100.
Measured: through study completion, an average of 1year
%FMM
FMM was calculated using stem-and-crown model as described in the parent study. (2) FMM of each diagonal brach was converted to percent FMM (%FMM) of diagonal branch by dividing each FMM by left ventricular myocardial mass.
Measured: through study completion, an average of 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start3 Aug 2015
- Primary completion6 Feb 2017
- Study completion8 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bon-Kwon Koo
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Naju National Hospital, Chonnam National University Hospital, Samsung Medical Center, Ewha Womans University, Ajou University School of Medicine
- Responsible party
- Sponsor-investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935542
- Sponsor's protocol ID
- SB-FMM-prediction
- Status last verified
- Apr 2019
- First submitted
- 26 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
Publications
Paeng JC, Lee DS, Cheon GJ, Lee MM, Chung JK, Lee MC. Reproducibility of an automatic quantitation of regional myocardial wall motion and systolic thickening on gated 99mTc-sestamibi myocardial SPECT. J Nucl Med. 2001 May;42(5):695-700.
PubMed 11337562Kim HY, Lim HS, Doh JH, Nam CW, Shin ES, Koo BK, Yoon MH, Tahk SJ, Kang DK, Song YB, Hahn JY, Choi SH, Gwon HC, Lee SH, Kim EK, Kim SM, Choe Y, Choi JH. Physiological Severity of Coronary Artery Stenosis Depends on the Amount of Myocardial Mass Subtended by the Coronary Artery. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1548-60. doi: 10.1016/j.jcin.2016.04.008. Epub 2016 Jul 13.
PubMed 27423225Jeon WK, Park J, Koo BK, Suh M, Yang S, Kim HY, Lee JM, Kim KJ, Choi JH, Lim HS, Paeng JC, Hwang D, Kim HS; Collaborators. Anatomical attributes of clinically relevant diagonal branches in patients with left anterior descending coronary artery bifurcation lesions. EuroIntervention. 2020 Oct 9;16(9):e715-e723. doi: 10.4244/EIJ-D-19-00534.
PubMed 31719001
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Attributes of Clinically Relevant Diagonal Branches in Patients With Left Anterior Descending Coronary Artery Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT03935542
- Acronym / sponsor ID
- SB-FMM-prediction
- Conditions
- Stable Angina, Unstable Angina
- Keywords
- Bifurcation, Side branch, Ischemia, Myocardium, Revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Bon-Kwon KooUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Naju National Hospital, Chonnam National University Hospital, Samsung Medical Center, Ewha Womans University, Ajou University School of Medicine
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 2 May 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 performed to investigate the anatomical attributes that determine myocardial territory of diagonal branches and to develop a prediction model for clinically relevant branches using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).
Detailed description
Bifurcation lesion is one of the most challenging lesion subsets in the field of percutaneous coronary intervention (PCI). Despite the recent advances in PCI techniques and stent technology, most randomized studies failed to prove the superiority of systematic 2 stenting strategy compared with provisional side branch intervention strategy.
A certain amount of ischemic burden is required to achieve the benefit of revascularization over medical treatment. Compared with major epicardial vessels, side branches are smaller, more variable in anatomy, supplying less myocardium and less clinically relevant. Therefore, it is important to assess the myocardial mass at risk of side branches to determine the appropriate treatment strategy for bifurcation lesions. However, how to define the clinically relevant side branches which can be associated with the benefit of revascularization in a cardiac catheterization laboratory is not well-known.
The investigators performed this study to investigate the anatomical attributes that determine ischemic burden and myocardial territory of diagonal branches and to develop a prediction model for a clinically relevant diagonal branch using myocardial perfusion imaging (MPI) and coronary CT angiography (CCTA).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPI arm | – | –For the MPI arm, patients with severe jailed diagonal branch disease with available MPI in 3 months were selected from the Seoul National University Hospital Cardiac Catheterization and MPI database. |
| CCTA arm | – | –For the CCTA arm, patients from a previous multicenter prospective CCTA registry were retrospectively reviewed for a post-hoc analysis. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angina pectoris
Key inclusion criteria (2 listed)
- Patients with severe jailed diagonal branch disease with available MPI in 3 months (MPI arm)
- Patients who had available FMM value of diagonal branches from a previous multicenter prospective CCTA registry (CCTA arm)
Key exclusion criteria (2 listed)
- Patients with >50% stenosis at left anterior descending coronary artery (LAD) or left circumflex artery (LCx), regional wall motion abnormality at LAD territory (MPI arm)
- Patients with diffuse diagonal branch disease (CCTA arm)
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
Angiographic attributes for diagonal branches
Time frame: through study completion, an average of 1year
Angiographic attributes for diagonal branches were visually defined as follows : 1. Size was a binary attribute of vessel diameter ≥ 2.5mm or < 2.5mm. 2. Number was counted as one, two, and 3 or more diagonal branches. 3. Dominancy in patients with 2 diagonal branches (D1/2 dominancy) was a binary attribute for one of two diagonal branches whose diameter was more than two times larger than its smaller counterpart. 4. LCx dominancy was defined as a left-dominant system or a presence of obtuse marginal branch originating within proximal 1/3 of LCx and crossing LAD at right anterior oblique caudal view.
Sensitivity of prediction model
Time frame: through study completion, an average of 1year
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Specificity of prediction model
Time frame: through study completion, an average of 1year
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Negative predictive value of prediction model
Time frame: through study completion, an average of 1year
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Positive predictive value of prediction model
Time frame: through study completion, an average of 1year
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Area under the curve of prediction model
Time frame: through study completion, an average of 1year
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Accuracy of prediction model
Time frame: through study completion, an average of 1year
Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
2 secondary outcomes
%Ischemia
Time frame: through study completion, an average of 1year
%FMM
Time frame: through study completion, an average of 1year
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 May 2019.
- Background: PubMed 11337562Paeng JC, Lee DS, Cheon GJ, Lee MM, Chung JK, Lee MC. Reproducibility of an automatic quantitation of regional myocardial wall motion and systolic thickening on gated 99mTc-sestamibi myocardial SPECT. J Nucl Med. 2001 May;42(5):695-700.
- Background: PubMed 27423225Kim HY, Lim HS, Doh JH, Nam CW, Shin ES, Koo BK, Yoon MH, Tahk SJ, Kang DK, Song YB, Hahn JY, Choi SH, Gwon HC, Lee SH, Kim EK, Kim SM, Choe Y, Choi JH. Physiological Severity of Coronary Artery Stenosis Depends on the Amount of Myocardial Mass Subtended by the Coronary Artery. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1548-60. doi: 10.1016/j.jcin.2016.04.008. Epub 2016 Jul 13.
- Derived from this study: PubMed 31719001Jeon WK, Park J, Koo BK, Suh M, Yang S, Kim HY, Lee JM, Kim KJ, Choi JH, Lim HS, Paeng JC, Hwang D, Kim HS; Collaborators. Anatomical attributes of clinically relevant diagonal branches in patients with left anterior descending coronary artery bifurcation lesions. EuroIntervention. 2020 Oct 9;16(9):e715-e723. doi: 10.4244/EIJ-D-19-00534.
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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.
Bon-Kwon Koo, MD, PhD principal investigator
Seoul National University Hospital
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 Stable Angina and Unstable Angina, run by Bon-Kwon Koo 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 2 inclusion and 2 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 May 2019. 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?
Angiographic attributes for diagonal branches (time frame: through study completion, an average of 1year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935542, which also lists 3 linked publications.
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 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.