4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Assessment of Diagonal Branch Territory

Assessment of Diagonal Branch Territory

Study Description
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).

Condition or disease
Stable Angina Unstable Angina

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
Layout table for study information
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
Arms and Interventions
Group/Cohort
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.
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. %Ischemia [ Time Frame: through study completion, an average of 1year ]
    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.

  2. %FMM [ Time Frame: through study completion, an average of 1year ]
    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.


Eligibility Criteria
Layout table for eligibility information
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
Study Population
Patients with angina pectoris
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bon-Kwon Koo
Seoul National University Hospital
Naju National Hospital
Chonnam National University Hospital
Samsung Medical Center
Ewha Womans University
Ajou University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
Tracking Information
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
 (submitted: April 30, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 30, 2019)
  • %Ischemia [ Time Frame: through study completion, an average of 1year ]
    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.
  • %FMM [ Time Frame: through study completion, an average of 1year ]
    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.
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with angina pectoris
Condition
  • Stable Angina
  • Unstable Angina
Intervention Not Provided
Study Groups/Cohorts
  • 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.
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.
  • Kim 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.
  • Jeon 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2019)
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:

  • 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)

Exclusion Criteria:

  • 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)
Sex/Gender
Sexes Eligible for Study: All
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
  • Seoul National University Hospital
  • Naju National Hospital
  • Chonnam National University Hospital
  • Samsung Medical Center
  • Ewha Womans University
  • Ajou University School of Medicine
Investigators
Principal Investigator: Bon-Kwon Koo, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2019