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Assessment of Diagonal Branch Territory

Anatomical Attributes of Clinically Relevant Diagonal Branches in Patients With Left Anterior Descending Coronary Artery Bifurcation Lesions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03935542
Enrollment
355
Registered
2019-05-02
Start date
2015-08-03
Completion date
2018-10-08
Last updated
2019-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Angina, Unstable Angina

Keywords

Bifurcation, Side branch, Ischemia, Myocardium, Revascularization

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).

Interventions

None listed

Sponsors

Seoul National University Hospital
CollaboratorOTHER
Naju National Hospital
CollaboratorOTHER
Chonnam National University Hospital
CollaboratorOTHER
Samsung Medical Center
CollaboratorOTHER
Ewha Womans University
CollaboratorOTHER
Ajou University School of Medicine
CollaboratorOTHER
Bon-Kwon Koo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of prediction modelthrough study completion, an average of 1yearPrediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Positive predictive value of prediction modelthrough study completion, an average of 1yearPrediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Area under the curve of prediction modelthrough study completion, an average of 1yearPrediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Angiographic attributes for diagonal branchesthrough study completion, an average of 1yearAngiographic 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 modelthrough study completion, an average of 1yearPrediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Specificity of prediction modelthrough study completion, an average of 1yearPrediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.
Negative predictive value of prediction modelthrough study completion, an average of 1yearPrediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.

Secondary

MeasureTime frameDescription
%Ischemiathrough study completion, an average of 1yearMyocardium 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.
%FMMthrough study completion, an average of 1yearFMM 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026