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Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion (IVUS-CAMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02845505
Recruitment Status : Unknown
Verified September 2018 by Young-Hak Kim, MD, PhD, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : July 27, 2016
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Young-Hak Kim, MD, PhD, Asan Medical Center

Brief Summary:
The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the IVUS information about myocardial territory and stenosis severity and predicts the extent of CAMS-derived myocardial size.

Condition or disease Intervention/treatment
Coronary Artery Disease Other: Intravascular Ultrasound, coronary computed tomography angiography

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion
Actual Study Start Date : August 22, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans Ultrasound

Group/Cohort Intervention/treatment
IVUS-CAMS
patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS
Other: Intravascular Ultrasound, coronary computed tomography angiography



Primary Outcome Measures :
  1. mathematically-predicted ischemic size (by using IVUS parameters) vs. CAMS-derived myocardial size subtended to the stenotic segment [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Impact of plaque characteristics (attenuated plaque, plaque rupture, calcification, thrombosis, etc.) assessed by IVUS on the ischemic burden assessed by CAMS [ Time Frame: 1 year ]
  2. Incidence of MACE comprising death, nonfatal myocardial infarction or target vessel revascularization [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who undergo coronary computed tomography angiography, invasive coronary angiography and IVUS assessment prior to intervention will be enrolled. The patients should have at least one coronary artery lesion (including non-left main and isolated left main disease) with visually estimated diameter stenosis >50%
Criteria

Inclusion Criteria:

  • Age 20years or older
  • Patients who have at least one epicardial coronary artery lesion (including isolated left main disease or side branch) with visually estimated diameter stenosis >50% and take coronary angiography, CT angiography and IVUS
  • Willing and able to provide informed written consent

Exclusion Criteria:

  • In-stent restenosis
  • Bypass graft
  • Suspected coronary spasm even after sufficient nitrate injected
  • Cases in which the IVUS imaging catheter failed to cross the lesion
  • Poor quality IVUS or CT images
  • Visible collateral flow on angiography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845505


Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-Gu, Korea, Republic of
Contact: Young-Hak Kim, MD, PhD    82-2-3010-3955    mdyhkim@amc.seoul.kr   
Principal Investigator: Young-Hak Kim, MD,PhD         
Hallym University Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of
Contact: Hyun-Sook Kim, MD       heartsk@hotmail.com   
Principal Investigator: Hyun-Sook Kim, MD         
Sub-Investigator: Hye-Jeon Hwang, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae-Hwan Lee, MD       myheart@cnu.ac.kr   
Principal Investigator: Jae-Hwan Lee, MD         
Gangneung Asan Hospital Recruiting
Gangwon, Korea, Republic of
Contact: Sang Yong Yoo, MD       bovio@naver.com   
Principal Investigator: Sang Yong Yoo, MD         
Suk Won,Choi Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Suk Won Choi, M.D.       swchoi97@gamil.com   
Principal Investigator: Suk Won Choi, M.D.         
Inje university Pusan Paik hospital Recruiting
Pusan, Korea, Republic of
Contact: Tae Hyun Yang, MD       yangthmd@naver.com   
Principal Investigator: Tae Hyun Yang, MD         
Kosin University Gospel Hospital Recruiting
Pusan, Korea, Republic of
Contact: Jeong Ho Heo, MD       duggymdc@gmail.com   
Principal Investigator: Jeong Ho Heo, MD         
Pusan National University Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: Joon-Hyuk Oh, MD       jhoh724@hanmail.net   
Principal Investigator: Joon-Hyuk Oh, MD         
Pusan National University Yangsan Hospital Recruiting
Pusan, Korea, Republic of
Contact: Sang-Hyun Lee, MD       greenral@naver.com   
Principal Investigator: Sang-Hyun Lee, MD         
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jong-Young Lee, MD       jyleeheart@naver.com   
Principal Investigator: Jong-Young Lee, MD         
Veterans Hospital Medical Center Recruiting
Seoul, Korea, Republic of
Contact: ChangHoon Lee, MD       changhoon.lee121@gmail.com   
Principal Investigator: ChangHoon Lee, MD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Gyung-Min Park, MD       min8684@hanmail.net   
Principal Investigator: Gyung-Min Park, MD         
Sponsors and Collaborators
Asan Medical Center
Boston Scientific Corporation
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Responsible Party: Young-Hak Kim, MD, PhD, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02845505    
Other Study ID Numbers: AMCCV 2016-06
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Keywords provided by Young-Hak Kim, MD, PhD, Asan Medical Center:
intravascular ultrasonography
Computed Tomography
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases