Assessment of Diagonal Branch Territory

Stable Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03935542
• Other study ID #: SB-FMM-prediction
• Status: Completed
• Start date: August 3, 2015
• Est. completion date: October 8, 2018

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: October 8, 2018
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Stable Angina
• Unstable Angina

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (7)

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

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1year
Primary	Sensitivity of prediction model	Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.	through study completion, an average of 1year
Primary	Specificity of prediction model	Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.	through study completion, an average of 1year
Primary	Negative predictive value of prediction model	Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.	through study completion, an average of 1year
Primary	Positive predictive value of prediction model	Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.	through study completion, an average of 1year
Primary	Area under the curve of prediction model	Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.	through study completion, an average of 1year
Primary	Accuracy of prediction model	Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.	through study completion, an average of 1year
Secondary	%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.	through study completion, an average of 1year
Secondary	%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.	through study completion, an average of 1year