Assessment of Diagonal Branch Territory

April 30, 2019 updated by: Bon-Kwon Koo

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

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).

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

355

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with angina pectoris

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1year
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.
through study completion, an average of 1year
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.
through study completion, an average of 1year
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.
through study completion, an average of 1year
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.
through study completion, an average of 1year
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.
through study completion, an average of 1year
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.
through study completion, an average of 1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
%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.
through study completion, an average of 1year
%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.
through study completion, an average of 1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bon-Kwon Koo

Collaborators

Samsung Medical Center
Chonnam National University Hospital
Seoul National University Hospital
Ajou University School of Medicine
Ewha Womans University
Naju National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 3, 2015

Primary Completion (ACTUAL)

February 6, 2017

Study Completion (ACTUAL)

October 8, 2018

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (ACTUAL)

May 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-FMM-prediction

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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