Assessment of Diagonal Branch Territory

NCT03935542 | Completed

• 1 other identifier: SB-FMM-prediction
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

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).

Conditions

Stable Angina; Unstable Angina

Keywords

Bifurcation; Side branch; Ischemia; Myocardium; Revascularization

Outcome Measures

Primary Outcomes (7)

• Angiographic attributes for diagonal branches

  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

  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

  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

  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

  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

  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

  Prediction model using anatomical attributes to define clinical relevance of diagonal branches will be developed.

  through study completion, an average of 1year

Secondary Outcomes (2)

• %Ischemia

  through study completion, an average of 1year

• %FMM

  through study completion, an average of 1year

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with angina pectoris

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bon-Kwon Koo: lead
• Seoul National University Hospital: collaborator
• Naju National Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Samsung Medical Center: collaborator
• Ewha Womans University: collaborator
• Ajou University School of Medicine: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (3)

• 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.

  PMID: 11337562 BACKGROUND

• 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.

  PMID: 27423225 BACKGROUND

• 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.

  PMID: 31719001 DERIVED

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 2, 2019
• Study Start: August 3, 2015
• Primary Completion: February 6, 2017
• Study Completion: October 8, 2018
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

KR (1)