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Completed

NCT Number: NCT03935542

Assessment of Diagonal Branch Territory

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).

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Ischemia Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Unstable Angina Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 :

    • 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.

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bon-Kwon Koo

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 2, 2019
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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