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CTRI Number  CTRI/2019/12/022539 [Registered on: 27/12/2019] Trial Registered Prospectively
Last Modified On: 27/02/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Observational study to compare the reliability and inter-observer variability of three imaging techniques (optical coherence tomography, intravascular ultrasound and angiography) used for stenting in a hospital set-up in India. 
Scientific Title of Study   A Prospective, Observational Study to Investigate the Reliability of Optical Coherence Tomography (OCT) Compared to Intra-Vascular Ultra Sound (IVUS) and Angiography in Percutaneous Coronary Intervention (PCI) and Evaluate the Inter-Observer Variability of these technologies at a Tertiary PCI Centre in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tejas Patel  
Designation  Chairman 
Affiliation  Apex Heart Institute 
Address  Department of Cardiology, Apex Heart Institute, G-K Mondeal Business Park, Near Gurudwara, S.G. Highway Ahmadabad

Ahmadabad
GUJARAT
380059
India 
Phone    
Fax    
Email  tejaspatel@apexheart.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejas Patel  
Designation  Chairman 
Affiliation  Apex Heart Institute 
Address  SG Highway, Ahmedabad, Gujarat


GUJARAT
380059
India 
Phone    
Fax    
Email  tejaspatel@apexheart.in  
 
Details of Contact Person
Public Query
 
Name  Dr Tejas Patel  
Designation  Chairman 
Affiliation  Apex Heart Institute 
Address  SG Highway, Ahmedabad, Gujarat


GUJARAT
380059
India 
Phone    
Fax    
Email  tejaspatel@apexheart.in  
 
Source of Monetary or Material Support  
St Jude Medical India Pvt Ltd, 1-11-250/A, Matarani Sensation Building, Lane Besides Syndicate Bank, Begumpet, HYDERABAD, INDIA 500016  
 
Primary Sponsor  
Name  Apex Heart Institute 
Address  SG Highway, Ahmedabad, Gujarat  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejas patel  Apex Heart Institute  Department of Cardiology, Apex Heart Institute, G-K Mondeal Business Park, Near Gurudwara, S.G. Highway Ahmadabad
Ahmadabad
GUJARAT 
9824030576

tejaspatel@apexheart.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Apex Heart Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I20-I25||Ischemic heart diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Age >18 years
2. Patients willing to sign informed consent
3. Patients undergoing coronary angiography, OCT and IVUS, as per the discretion of treating physician
 
 
ExclusionCriteria 
Details  1. Patients unwilling to sign the informed consent
2. Patients with left main coronary artery lesion, coronary bypass graft lesion, chronic total occlusion, extremely tortuous vessel, or renal insufficiency with serum creatinine >2.0 mg/dL
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. Comparison of coronary assessments and treatment strategy between OCT and IVUS  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Standard Error Measurement of Inter-observer variability amongst fellows  Baseline 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/12/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Coronary angiography is routinely used to assess the extent and severity of coronary artery disease and for decision-making during percutaneous coronary interventions (PCI). However, angiography may sometimes be inadequate for deciding a treatment strategy and defining optimal stenting outcomes.  Intravascular imaging-guided PCI (intravascular ultrasound [IVUS] and optical coherence tomography [OCT]) has emerged as an effective alternative to coronary angiography-guided PCI.1  Both IVUS and OCT are analogous in that they send out energy waves (OCT uses light and IVUS uses sound waves) into the vessel wall and the energy that is sent back to the catheter is used to reconstruct an image.2,3 However, each technique has its own advantages and limitations.

 

Intravascular ultrasound has been established as a reliable imaging tool to guide stenting of complex lesions, including coverage of ostial lesions, bifurcation lesions, left main stenting, and chronic total occlusions. Further, it is useful in determining the cause of stent failures, including in-stent restenosis. IVUS examinations have also significantly increased our understanding of the mechanisms of balloon angioplasty, stent implantation, and restenosis.4 A major advantage of IVUS over OCT is its penetration of 4-8 mm inside the vessel wall. The light-based OCT technology can only penetrate about 2-3 mm. If a vessel has significantly remodelled due to plaque burden, the outline of the true lumen disappears on the OCT image and it may be difficult for the interventionalist to assess the extent of the plaque.3 Despite its benefits, the use of IVUS has been noted to be limited to <20% of percutaneous coronary intervention (PCI) procedures.4

 

On the other hand, OCT has greater spatial resolution than IVUS2,5,6 and studies have shown that it provides more details regarding the microstructure of the vessel wall than IVUS.2,7 Specifically, OCT has been shown to identify thin-cap fibroatheroma (TCFA), a feature that may not be possibly detected with precision by IVUS.8-11 Further, intimal hyperplasia, internal and external elastic laminae, echolucent regions corresponding to large lipid pools, tissue protrusion, edge dissection, and incomplete stent apposition may be more frequently identified by OCT- versus IVUS-imaging.8,12,13  

 

Considering the benefits of IVUS and OCT over angiography, and the individual limitations and advantages of IVUS and OCT, it may be important to understand the comparative reliability of each of these techniques for coronary measurements and treatment decision-making and assess interindividual variability, if any of the coronary measurements by these methods.


  1. Buccheri SFranchina GRomano S, et al. Clinical outcomes following intravascular imaging-guided versus coronary angiography-guided percutaneous coronary intervention with stent implantation: A systematic review and Bayesian network meta-analysis of 31 studies and 17,882 patients. JACC Cardiovasc Interv. 2017;10(24):2488-2498.

  2. Prati FRegar EMintz GS, et al. Expert review document on methodology, terminology, and clinical applications of opticalcoherence tomography: Physical principles, methodology of image acquisition, and clinicalapplication for assessment of coronary arteries and atherosclerosis. Eur Heart J. 2010;31(4):401-15.

  3. Fornell D. The advantages and disadvantages of OCT vs. IVUS.  DAC, 2011. Available at: https://www.dicardiology.com/article/advantages-and-disadvantages-oct-vs-ivus. Accessed on: 22 Sep 2019

  4. Waksman R, Kitabata H, Prati F, et al. Intravascular ultrasound versus optical coherence tomography guidance. J Am Coll Cardiol. 2013; 62 (17): Suppl S

  5. Mintz GS, Nissen SE, Anderson WD, et al. American College of Cardiology Clinical Expert Consensus Document on Standards for Acquisition, Measurement and Reporting of Intravascular Ultrasound Studies (IVUS). A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2001;37:1478–92. 

  6. Garcìa-Garcìa HM, Gogas BD, Serruys PW, et al. IVUS-based imaging modalities for tissue characterization: similarities and differences. Int J Cardiovasc Imaging. 2011;27:215–224.  

  7. Prati F, Guagliumi G, Mintz GS, et al. Expert review document part 2: Methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures. Eur Heart J. 2012;33(20):2513-20.

  8. Jang IK, Bouma BE, Kang DH et al. Visualization of coronary atherosclerotic plaques in patients using optical coherence tomography: Comparison with intravascular ultrasound. J Am Coll Cardiol. 2002;39:604–609. 

  9. Jang IK, Tearney GJ, MacNeill B et al. In vivo characterization of coronary atherosclerotic plaque by use of optical coherence tomography. Circulation. 2005;111:1551–5.

  10. Tanaka A, Imanishi T, Kitabata H, et al. Lipid-rich plaque and myocardial perfusion after successful stenting in patients with non-ST-segment elevation acute coronary syndrome: an optical coherence tomography study. Eur Heart J. 2009;30:1348–55.

  11. Rathod KS, et al. Intravascular ultrasound versus optical coherence tomography for coronary artery imaging – Apples and oranges? International Cardiol Rev. 2015;10(1):8-15.

  12. Kim ICYoon HJShin ES, et al. Usefulness of frequency domain optical coherence tomography compared with intravascular ultrasound as a guidance for percutaneous coronary intervention. J Interv Cardiol. 2016;29(2):216-24.

  13. Maehara ABen-Yehuda OAli Z, et al Comparison of stent expansion guided by optical coherence tomography versus intravascular ultrasound: The ILUMIEN II study (Observational Study of Optical Coherence Tomography [OCT] in Patients Undergoing Fractional Flow Reserve [FFR] and Percutaneous Coronary Intervention). JACC Cardiovasc Interv. 2015;8(13):1704-14. 

  14. Kubo T, Akasaka T, Shite J, et al. OCT compared with IVUS in a coronary lesion assessment: the OPUS-CLASS study. JACC Cardiovasc Imaging. 2013;6(10):1095-1104

 
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