Clinical trial NCT03935542: Assessment of Diagonal Branch Territory
Official title: Anatomical Attributes of Clinically Relevant Diagonal Branches in Patients With Left Anterior Descending Coronary Artery Bifurcation Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Unstable Angina
Keywords: Bifurcation
Side branch
Ischemia
Myocardium
Revascularization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Naju National Hospital
name: Chonnam National University Hospital
name: Samsung Medical Center
name: Ewha Womans University
name: Ajou University School of Medicine
First posted: 2019-05-02
Enrollment: 355
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with angina pectoris

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).

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)

Primary outcomes:
measure: Angiographic attributes for diagonal branches
timeFrame: through study completion, an average of 1year
measure: Sensitivity of prediction model
timeFrame: through study completion, an average of 1year
measure: Specificity of prediction model
timeFrame: through study completion, an average of 1year
measure: Negative predictive value of prediction model
timeFrame: through study completion, an average of 1year
measure: Positive predictive value of prediction model
timeFrame: through study completion, an average of 1year
measure: Area under the curve of prediction model
timeFrame: through study completion, an average of 1year
measure: Accuracy of prediction model
timeFrame: through study completion, an average of 1year
Secondary outcomes:
measure: %Ischemia
timeFrame: through study completion, an average of 1year
measure: %FMM
timeFrame: through study completion, an average of 1year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.