Condition or disease |
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Stable Angina Unstable Angina |
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 Type : | Observational |
Actual Enrollment : | 355 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Anatomical Attributes of Clinically Relevant Diagonal Branches in Patients With Left Anterior Descending Coronary Artery Bifurcation Lesions |
Actual Study Start Date : | August 3, 2015 |
Actual Primary Completion Date : | February 6, 2017 |
Actual Study Completion Date : | October 8, 2018 |
Group/Cohort |
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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.
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CCTA arm
For the CCTA arm, patients from a previous multicenter prospective CCTA registry were retrospectively reviewed for a post-hoc analysis.
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Angiographic attributes for diagonal branches were visually defined as follows :
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Bon-Kwon Koo, MD, PhD | Seoul National University Hospital |
Tracking Information | ||||
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First Submitted Date | April 26, 2019 | |||
First Posted Date | May 2, 2019 | |||
Last Update Posted Date | May 2, 2019 | |||
Actual Study Start Date | August 3, 2015 | |||
Actual Primary Completion Date | February 6, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Assessment of Diagonal Branch Territory | |||
Official Title | Anatomical Attributes of Clinically Relevant Diagonal Branches in Patients With Left Anterior Descending Coronary Artery Bifurcation Lesions | |||
Brief 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). | |||
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). |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients with angina pectoris | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
355 | |||
Original Actual Enrollment | Same as current | |||
Actual Study Completion Date | October 8, 2018 | |||
Actual Primary Completion Date | February 6, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT03935542 | |||
Other Study ID Numbers | SB-FMM-prediction | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bon-Kwon Koo, Seoul National University Hospital | |||
Study Sponsor | Bon-Kwon Koo | |||
Collaborators |
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Investigators |
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PRS Account | Seoul National University Hospital | |||
Verification Date | April 2019 |