High-Risk Plaques Identification Using Coronary Computed Tomography and Computational Fluid Dynamics
Conditions: Atherosclerosis and Blood Flow in Coronary Artery
Sponsor: Bangladesh University of Engineering and Technology

 
 
 
1 
 
Research Protocol: 
High-Risk Plaques Identification using Coronary Computed Tomography and 
Computational Fluid Dynamics 
 
 
Submitted to: 
Institutional Review Board 
BUET, Dhaka-1000, Bangladesh. 
 
Principal Investigator 
Prof. Dr. Muhammad Tarik Arafat 
Department of Biomedical Engineering 
BUET, Dhaka, Bangladesh. 
 
Co-Principal Investigator: 
Prof. (Dr.) M G Azam 
Professor of Cardiology 
MBBS, MD (Cardiology), FSCAI (USA) 
Clinical and Interventional Cardiologist 
Fellow, Interventional Cardiologist, Germany Professor of Cardiology 
National Institute of Cardiovascular Diseases (NICVD) 
LABAID Limited (Diagnostics) 
 
 
Date of Submission:28.08.24  
 

 
 
 
2 
 
DOCUMENTS TO BE SUBMITTED FOR ETHICAL APPROVAL 
01. 
Filled-up Ethical Clearance Application Form. (Annexure - A) 
 
02. 
Signature of Principal Investigator (s) & Co-investigator (s) with 
details address. (Annexure – A) 
 
03. 
Abstract 
for 
BME 
Ethical Review 
Committee 
(BMEERC)     
(Annexure - B) 
 
04. 
BMRC format for Submission of the Proposal for Ethical Approval 
(Annexure - C) 
 
05. 
Informed consent form (Both Bangla and English) from participants 
or from the Parent / legal guardian. (Annexure - D) 
 
06. 
Budget (Annexure - E) 

 
 
 
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ANNEXURE - A 
Application for Ethical Clearance 
1. 
Principal Investigator(s):  
Name: Dr. Muhammad Tarik Arafat 
Qualification: Professor 
Detail Address: Department of Biomedical Engineering, BUET, Dhaka, Bangladesh. 
Phone: +(880 2) 55167100 
e-mail: tarikarafat@bme.buet.ac.bd 
2. 
Co-Investigator(s): 
Name: Dr. M G Azam 
Qualification: Professor of Cardiology, MBBS, MD (Cardiology), FSCAI (USA) 
Detail Address: Room No-301, Middle Block, NICVD, Dhaka 
3. 
Place of the Study/Institution(s): Department of Interventional Cardiology, National 
Institute of Cardiovascular Diseases & Hospital (Data Collection). Biomechanics Lab, BME, 
BUET ( CFD & statistical analysis) 
4. 
Title of Study: High-Risk Plaques Identification using Coronary Computed 
Tomographic Angiography and Computational Fluid Dynamics. 
5. 
Type of Study: Observational Study 
6. 
Duration of Study: 6 months 
7. 
Total Cost: Tk. 80,000/- 
8. 
Funding Agency: N/A 
 

 
 
 
4 
 
Circle the appropriate answer to each of the following 
(If not Applicable write NA) 
 
1. Source of Population: 
 
(a) ill Participant         
Yes  
No 
   
(b) Non-ill Participant  
Yes  
No 
   
(c) Minors or persons  
Yes  
No  
       under guardianship 
 
2. Does the study involve? 
 
   
(a)  Physical risks  
Yes  
No  
 
 
To the subjects  
 
   
(b)  Social Risks         
Yes  
No 
 
   
(c)  Psychological  
Yes  
No  
 
 
Risks to subjects 
 
   
(d)  Discomfort to  
Yes  
No  
       Subjects  
   
(e)  Invasion of the body  
Yes  
No   
   
(f)  Invasion of Privacy  
Yes  
No  
   
(g)  Disclosure of  
Yes  
No  
 
 
Information damaging to  
       Subject or others 
 
3. Does the study involve? 
 
 
(a)  Use of records,  
Yes  
No  
       
(Hospital, medical,  
       
Death, birth or other) 
 
  
(b)  Use of fetal tissue  
Yes  
No  
       
Or abortus 
  
(c)  Use of organs or  
Yes  
No  
       
Body fluids 
 
 
 
 
4. Are subjects clearly informed about? 
  
(a)  Nature and         
Yes  
No  
 
 
       purposes of study 
  
(b)  Procedures to be  
Yes  
No 
       
followed including  
 
(c)  Physical risks  
Yes  
No 
  
(d)   Private questions 
Yes  
No 
      (e)  Invasion of the  
Yes  
No 
       
Body 
 
  
(f)  Benefits to be  
Yes  
No 
     
Derived 
 
  
(g)  Right to refuse  
Yes  
No 
       
to participate or  
       
to withdraw from study 
 
  
(h)  Confidential  
Yes  
No 
       
handling of data 
 
  
(i)  Compensation  
N/A 
 
       where there are risks or  
 
 
loss of working time or  
 
 
privacy is involved in  
 
 
any particular procedure 
5. Will signed consent form/verbal consent be 
required? 
  
(a)  From Subjects  
Yes  
No 
  
(b)  From parent or  
N/A  
       
guardian (if subjects are minors) 
6. Will precautions be  
Yes  
No  
 
taken to protect  
   
anonymity of subjects 
 

 
 
 
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Note: If the final instrument / questionnaire is not completed prior to review, the following information 
should be included in the abstract. 
1.  
A description of the areas to be covered in the questionnaire or interview which could be considered 
either sensitive or which would constitute an invasion of privacy. 
2.  
Examples of the type of specific question to be asked in the sensitive areas. 
3.  
An indication as to whom the questionnaire will be presented to the committee for review. 
 
 
We agree to obtain approval of the Ethical Review Committee for any changes involving the rights 
and welfare of subjects or any changes of the Methodology before making any such changes. 
 
                     Signature 
Prof. Dr. Muhammad Tarik Arafat 
Professor, Department of Biomedical Engineering 
BUET, Dhaka, Bangladesh. 
Date:         
      
 
 
Name of Co-investigator (S)                                                 Signature: 
 
 
 
 
 
1. Name:  
Prof. (Dr.) M G Azam 
Qualification: 
 Professor of Cardiology, MBBS, MD (Cardiology), FSCAI (USA) 
Detail Address: Room No-301, Middle Block, NICVD, Dhaka 

 
 
 
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ANNEXURE - B 
PREPARATION OF AN ABSTRACT  
 
The Ethical Review Committee will not consider any application which does not include a specific 
abstract/summary for the committee. The abstract should summarize the purpose of the study, the methods 
and procedures to be used, by addressing each of the following items. If an item is not applicable, please 
note accordingly: 
 
1. 
Describe the requirements in respect of the population and explain the rationale for using 
population of special groups such as children, Incompetent person or groups whose ability to give 
voluntary informed consent is questionable. 
Response: This study was a single center observational study who underwent Computed 
Tomography (CT) for coronary artery disease in our institute. Patients who had advanced kidney 
disease, hemodialysis, severe liver disease, hyperthyroidism, and a history of coronary bypass 
surgery were all excluded. 
2. 
Describe and assess any potential risks - physical, psychological, social, legal or other and assess 
the likelihood and seriousness of such risks. If methods of research create potential risks, describe 
other methods, if any, that were considered and why they cannot be used. 
Response: CFD analysis often requires imaging techniques like CT or MRI. Repeated imaging 
can expose patients to radiation, potentially increasing the risk of radiation-induced conditions. 
Use of contrast agents in imaging can cause allergic reactions or kidney damage. Patients 
diagnosed with cardiovascular diseases might face social stigma, affecting their personal and 
professional relationships. Handling sensitive patient data poses risks of data breaches and 
unauthorized access. 
Despite the potential risks, the use of imaging techniques combined with CFD provides 
unparalleled precision in identifying plaque rupture risks. The benefits of accurate diagnosis and 
the ability to tailor treatment plans outweigh the potential risks, provided that stringent safety 
protocols are followed. This includes minimizing radiation exposure, using non-invasive 
methods when possible, ensuring thorough patient education and consent, and protecting patient 
data. 
Alternative Methods Considered: - 
i. 
Non-Invasive Imaging (e.g., Ultrasound):- While safer, these methods may not provide 
the detailed information required for accurate CFD analysis. 
Reason for Not Using: Insufficient detail and accuracy for CFD modeling. 
ii. 
Biomarkers:- Blood tests for inflammatory markers can indicate risk but cannot provide 
detailed spatial information about plaque stability. 

 
 
 
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Reason for Not Using: Lack of spatial resolution and precision. 
3. 
Describe procedures for protecting against or minimizing potential risks and assessment of their 
likely effectiveness. 
Response: Use of low-dose imaging protocols, and limiting the frequency of imaging to essential 
instances only. Advances in imaging technology have significantly reduced radiation doses while 
maintaining image quality. Pre-screening patients for allergies and renal function, using non-
contrast imaging techniques when possible, and ensuring adequate hydration before and after the 
procedure. Proper pre-screening and hydration can significantly reduce the risk of adverse 
reactions. Utilize non-invasive imaging methods whenever possible, and strictly adhere to aseptic 
techniques during invasive procedures. Non-invasive imaging methods like MRI or CT can often 
replace invasive procedures, significantly reducing risks. 
Legal risks: Implementing robust data encryption, access controls, and regular audits to ensure 
compliance with data protection regulations. Strong data protection measures can significantly 
reduce the risk of data breaches. Developing comprehensive and easily understandable consent 
forms, and ensuring thorough discussions with patients about the risks and benefits. Properly 
informed consent processes can effectively mitigate legal risks. 
The effectiveness of all procedures is generally high, ensuring patient safety while maintaining 
diagnostic accuracy. 
4. 
Include a description of the methods for safeguarding confidentiality or protecting anonymity. 
Response: The data collected by the study physicians will be kept confidential at all times. 
Remove or anonymize personally identifiable information (PII) from datasets used for CFD 
analysis. Ensure patients are fully informed about how their data will be used, and obtain explicit 
consent for data use in research and analysis. Include details about anonymization and 
confidentiality measures in the consent process. The confidentiality and anonymity of patient 
data in CFD studies can be effectively safeguarded. These measures ensure that patient 
information is protected from unauthorized access and misuse while allowing for the accurate 
identification of plaque rupture risks in acute coronary syndrome. The combination of these 
procedures provides a robust framework for maintaining the highest standards of data privacy 
and patient confidentiality. 
5. 
When there are potential risks to the subject, or the privacy of the individual may be involved, 
the investigator is required to obtain a signed informed consent from the participant. For minors, 
informed consent must be obtained from the authorized legal guardian or parent of the subject. 
Describe consent procedures to be followed including how and where informed consent will be 
obtained. 
(a)  If signed consent will not be obtained, explain why this requirement should be waived and 
provide an alternative procedure such as a verbal consent. 
Response: Informed consent will be obtained. 

 
 
 
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(b) If information is to be withheld from a subject, justify this course of action.  
Response: No information will be withheld from the subject. 
(c)  If there is a potential risk to the subject or privacy of the individual or loss of work time is 
involved in any particular procedure, include a statement in the consent form stating whether any 
compensation will be available. 
Response: Not applicable since there is a minimal risk of privacy and loss of work time. This will be 
mentioned in the consent form. 
6. 
If the study involves an interview, describe where and in what context the interview will take 
place. State approximate length of time required for the interview. 
Response: This study will not require an interview. 
7. 
Assess the potential benefit to be gained by the individual subject as well as the benefits which 
may accrue to society in general as a result of the work. Indicate how the benefits may outweigh 
the risks. 
Response: computational fluid dynamics is a promising non-invasive tool that can help identify 
high-risk coronary plaques destined to cause acute coronary syndrome. CFD provides detailed 
analysis of blood flow and plaque characteristics, leading to a more accurate diagnosis of plaque 
rupture risk. Early identification and treatment of high-risk plaques can lead to a decrease in the 
incidence of acute coronary syndrome events. While there are physical risks associated with 
imaging and contrast agents, these are generally outweighed by the significant health benefits of 
accurate diagnosis and effective treatment. The use of non-invasive techniques and preventive 
measures can mitigate these risks, leading to better patient outcomes. With appropriate risk 
management strategies, the implementation of CFD in clinical practice offers a promising 
advancement in the fight against cardiovascular disease. 
8. 
Incase of an experimental drugs, provide information about its status of registration for open sale 
in Bangladesh and in other developed countries. 
Response: N/A 
9. 
For experimental 'new' drugs* which are not registered in Bangladesh provide full information 
about the toxicity studies carried out in animals or human volunteers. Published papers on this 
regard shall be annexed. 
Response: N/A 
10. 
If placebo is to be used justify its uses and why the study cannot be done without its use. 
Response: N/A 
11. 
If an experimental 'new' drug* is to be used state its sponsorship and the conditions for such 
sponsorship. 

 
 
 
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Response: N/A 
12. 
State if the activity requires the use of records (hospital, medical, birth, death or other), organs, 
tissues, body fluids, the fetus or the abortus. 
Response: Yes. The study will use the medical records, including: date of birth, CT angiogram, 
body fluids etc. 
The statement to the subject should include information specified in items 2, 3, 4, 5(c) and 7, as well as 
indicating the approximate time required for participation in the activity. 
 
* a 'new' drug means one which is not registered for free and open sale in Bangladesh. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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ANNEXURE - C 
 
Project Title: High-Risk Plaques Identification using Coronary Computed Tomography and 
Computational Fluid Dynamics. 
• Summary: 
 
The study investigates the use of advanced imaging techniques and computational methods to 
identify high-risk plaques in coronary arteries. These plaques are significant because they have the 
potential to cause acute coronary syndrome (ACS), a condition that includes heart attacks and 
unstable angina. The research focuses on the integration of Coronary Computed Tomography 
(CCT) with Computational Fluid Dynamics (CFD) to provide detailed insights into plaque 
characteristics and their hemodynamic environment. 
The primary aim of the study is to enhance the early detection and characterization of high-risk 
coronary plaques that could lead to ACS. By combining CCT, a non-invasive imaging technique, 
with CFD, which stimulates blood flow dynamics, the study seeks to: Identify High-Risk Plaques, 
Apply CFD to analyze the blood flow around these plaques, Improve Prediction of ACS, Inform 
Clinical Decision-Making. 
Computational fluid dynamics (CFD) analysis of CCT data can also provide a noninvasive 
hemodynamic assessment to identify high-risk plaques destined to cause acute coronary syndrome 
[1]. Patients with adverse plaque characteristics like positive remodeling or low-attenuation plaque 
have a greater risk of future coronary events [2-4]. 
 
▪ Introduction:  
 
Globally, Cardiovascular diseases (CVDs) are responsible for the highest fatalities where ACS is 
recognized to contribute to a good many of these effects [5-7]. ACS which involves myocardial 
infarction and unstable angina is mainly caused by the rupture or erosion of plaques in the arteries 
of the heart. So, early detection of the higher risk plaques that can cause an acute event and thereby, 
ACS is useful in optimizing patient’s survival data [8-11]. 
 
New imaging technology and computing methods have made it extremely easier to identify and 
evaluate these dangerous plaques. Coronary computed tomographic angiography or CCT is the 
most recent imaging technique specifically used for diagnoses of coronary artery diseases because 
of features such as better accuracy, minimally invasive imaging of the coronary arteries along with 
the characterization of plaque. Clinicians use CCT to signal elements such as positive remodeling, 
low attenuation plaque, napkin-ring sign, and spotty calcium. 
 
As useful as CCT is for plaque visualization, it doesn’t inform the analysis of hemodynamic loads 
on the plaques, which are paramount to plaque destabilization. This is the role of computational 
fluid dynamics (CFD) tools step in playing into this reason. CFD is a strong application imitating 
blood flow within the coronary arteries, whereby assessment of values such as WSS and plaque 
stress can be done[12-21]. All these parameters play a pivotal role in dissecting the biomechanical 
milieu of the plaques and in stratifying the lesions most prone to causing ACS. 
The combination of CCT with CFD assists in evaluating not only the major anatomic but also the 
hemodynamic facets that underlie plaque instability[22-25]. This approach does not only help to 
improve the identification of high-risk plaques, but it also helps to split the patients into groups 
according to their risk of development of ACS. Thus, the detection of patients with vulnerable 
plaques may enable clinicians to apply prevention and therapeutic approaches more efficiently and 

 
 
 
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effectively and prevent acute coronary events. 
 
To sum it up, the application of both coronary CTA and CFD should be regarded as a major 
progress in diagnosing CAD through noninvasive means.  
 
▪ Objectives: 
1. Identify High-Risk Plaque Features Using CCT. To compare the prevalence and 
distribution of the high-risk characteristics of the plaque among varying types of patients. 
2. To CFD to predict blood flow patterns in coronary arteries and quantify WSS and plaque 
stress environments.  
3. To associate the observed high-risk plaque features and hemodynamic data with clinical 
outcomes which include the rate of the future ACS.  
4. Improved risk stratification of patients with coronary artery disease to identify those at 
greatest risk of future ACS events. 
5. Enhance Non-Invasive Assessment Techniques: This would pave the way to the 
improvement of the knowledge in non-invasive cardiovascular imagining and 
computational modeling through the introduction of integrated CCT-CFD technique. 
To set best practice consensus documents regarding the application of CCT and CFD into 
clinical operative practice for the diagnosis of CAD. 
 
Study Hypothesis:  
 
The synergistic application of CCT and CFD helps to identify high-risk atherosclerotic plaques, 
which would be prone to causing ACS in the future, by assessing not only the morphological 
characteristics but also the hemodynamic factors, which helps in better risk estimation and 
management of the particular patient along with preventive and curative measures. the study’s 
purpose is to verify that CCT + CFD is highly effective for non-invasive diagnostic assessment of 
high-risk plaques, thus improving the capacity to anticipate and avoid acute coronary syndrome. 
 
▪ Rationale: 
 
In cardiovascular medicine, it is a major challenge to identify and prevent further progression of 
unstable atherosclerotic plaques that predispose to rupture and formation of ACS. ACS including 
myocardial infarction and unstable angina occurs when these tears or erosions of these susceptible 
plaques form thrombus and occlude the coronary blood flow. This study aims to determine the 
current level of ACS and the complications that occurred to identify the early detection and 
prevention of ASC in Bangladesh. Coronary computed tomography (CCT) combined with 
computational fluid dynamics (CFD) may solve these challenges in the Bangladeshi care setting. 
The incidences of CVDs such as the ACS have been on the rise in the last few decades in Bangladesh 
mainly due to urbanization, gradual change in many aspects of life such as diet and physical activity, 
and an aging population. The problems of CVDs due to their high prevalence pose a great economic 
and health care burden to a country such as Bangladesh.  
CCT is an invasive and cheap procedure compared to surgical one, and it can provide the physician 
with valuable information about the anatomical features of the coronary arteries and the plaques. 
CCT allows imaging of the lumen of the coronary arteries and the vessel wall at the same time, 
which means that it can distinguish between the plaques that do not cause such a significant 

 
 
 
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narrowing of the arteries as to be detected using other methods, but that are prone to rupture. Other 
quantifiable characteristics that are linked with plaque stability and risk of rupture are WSS or wall 
shear stress, and atherosclerotic plaque stress that are not implanted as well as cannot be assessed 
by CCT alone. As it has been mentioned before, it may be stated that CFD can model blood flow 
behavior in the coronary arteries which provides needed information about the specific given 
hemodynamical features. Therefore, it can be stated that applying CFD in combination with CCT 
provides the possibility to receive extensive information about particular anatomical features and 
biomechanical conditions contributing to the formation of plaques. Integration of CCT and CFD 
may assist in the identification of specific high-risk plaque and the prognosis of the development of 
ACS, thus benefiting patients’ outcomes. Implementation of this approach in the health facilities of 
Bangladesh will ensure a combination of the so-often practiced medical work and the newly 
developed diagnostic techniques. From the current trends of CVDs in Bangladesh, it is clear that 
new strategies for early identifying and improved preventive methods need to be developed. The 
integration of CCT and CFD programs into the structures of nationwide health care can play a great 
role in combatting the rise of the public health issue of ACS. Applying this concept of high-end 
diagnostic technologies can foster local research on cardiovascular diseases for the enrichment of 
humanity’s body of knowledge. Another way is that close cooperation with international research 
organizations will also be effectively useful for developing the competencies of Bangladeshi 
healthcare workers and researchers. This approach can overcome the shortcomings of the current 
diagnostics, give solutions at a lower cost, and create a huge difference in the public health of the 
country – Bangladesh. 
▪ Methodology: 
 
The locally adapted workflow for the identification of high-risk atherosclerotic plaques that may 
cause Acute Coronary Syndrome (ACS) based on the integration of CCT and CFD is carried out 
systematically. These are the steps in the presented methodology, namely, the patient cohort, 
imaging, data handling and analysis, CFD simulation, and clinical implementation. 
Firstly, select patients based on symptoms of coronary artery disease (CAD), high-risk factors (e.g., 
family history, hypertension, diabetes), or those requiring further evaluation after preliminary tests 
and then Preparation: Give drugs to achieve proper rate of heartbeat.The order includes checking 
the patient’s habits for proper hydration and contraindications to the use of contrast media. If we 
read this then follow CCT imaging protocol. Conduct CCT with the help of a multi-detector CT 
scanner only. Take detailed images of the coronary arteries. Plan to administer iodinated contrast 
material to improve the visual display of coronary arteries. Moreover, electrocardiographic gating 
ensures the timely exposure of the patient’s heart to radiation during the cardiac cycle to minimize 
motion. All the above processes have to be accomplished then the remaining work is taken care of 
by Mimics and Ansys Simulation software. Create reconstructions of the coronary arteries using 
Ansys software and out of the CCT data that was acquired. Grasp positive remodeling, low 
attenuation plaque, napkin ring sign, and spotty calcification in atherosclerotic plaques. Document 
the features you noticed about the plaques that are in the identified places; the sizes and the shapes 
and the location certainly. The working process is, to a large extent, sequential. When one of them 
is absent the other does not work, or does not operate within the protocol, we do not discover our 

 
 
 
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result. Following that, ‘‘Cut out’ the coronary artery regions of interest from the reconstructed 3D 
images. Develop a mesh based on the segmented coronary artery regions. This entails the 
segmentation of the artery into small parts that are useful in making a CFD analysis. CFD Simulation 
has some conditions that are important for the results of the research. 
Boundary Conditions: Define physiological boundary conditions, such as blood flow rates, 
pressure, and viscosity, based on patient-specific data. 
Simulation: Configure the CFD software with the segmented geometry and boundary conditions. 
Run the CFD simulations to calculate hemodynamic parameters, including wall shear stress (WSS), 
plaque stress, and flow velocity profiles. 
Data Analysis: Analyze the CFD results to understand the hemodynamic environment within the 
coronary arteries and identify regions with abnormal hemodynamic forces. 
After Completing the above processes, Integrate anatomical data from CCT (plaque characteristics) 
with hemodynamic data from CFD (WSS, plaque stress). Identify high-risk plaques based on 
combined criteria, including anatomical vulnerability and hemodynamic stress. Then, we Generate 
a detailed report summarizing the findings from CCT and CFD analysis. We Stratify patients into 
different risk categories (low, moderate, high) based on the comprehensive assessment. Finally, we 
will adjust the treatment plan based on the findings and analysis of the patient's response. 
Phase-3- (A Pilot Study):  
A pilot study is necessary to evaluate the accuracy and efficiency of Coronary Computed 
tomography (CCT) and Computational Fluid Dynamics (CFD) in helping distinguish high-risk 
plaques that may lead to Acute Coronary Syndrome (ACS). This pilot study will bring out some of 
the procedures to be used; fine-tune research procedures; and generate some data to be used in the 
main study. 
Objectives 
▪ 
To first determine whether CCT and CFD can be combined for proper identification of high-
risk plaques. 
▪ 
To assess the precision of this integrated method for early identification of ACS. 
▪ 
To assess the realistic problems and constraints in a clinical center. 
▪ 
To generate general data for forming more extensive and powerful research studies. 
With regards to the decision of sample size for a pilot study, it depends on different strategies used 
depending on the purpose of the pilot study. As this pilot study aims to investigate the feasibility of 
interventions and acquisition of preliminary efficacy data, one of the recognizable practices of 
defining the sample size is by using certain rules of thumb or certain formulas for proportion / means 
estimation. 
Estimation of sample size for a proportion 
If the pilot study aims to estimate the proportion of patients with high-risk plaques accurately, the 
sample size can be calculated using the following equation: If the pilot study aims to estimate the 

 
 
 
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proportion of patients with high-risk plaques accurately, the sample size can be calculated using the 
following equation: 
N = 
𝑍2 ×𝑝×(1−𝑝)
𝑑2
 
Where: 
N = perfectly sized sample 
Z = Z-value for the significance level e. g., for a 95% confidence level we use 1. 96. 
p = Rate or prevalence; estimated proportion of the population with high-risk plaques 
(assumed to be 0.5 if unknown for maximum sample size) 
d = required level of accuracy (for example, 0. 1 for 10%). 
Thus, this calculation indicates that it would require 96 participants to have precision in estimating 
the proportion. However, for the pilot study aimed at establishing the feasibility of the study and 
collecting the first figures, the number can be reduced. 
Since the purpose of this pilot study is to test survey efficacy and develop a sense of the magnitude 
of gender differences, a form of power analysis. 
Final Sample Size Recommendation: 50 participants 
▪ 
Utilization of Results:  
Applying these innovations in the form of CCT and CFD for risky plaque determination and ACS 
prevention can transform the treatment of cardiovascular diseases in Bangladesh. Therefore, this 
approach of early detection, accurate diagnostics, patient-tailored approaches, and better access to 
advanced diagnostics will allow for increasing the overall health and well-being of the population. 
Furthermore, it creates further chances of establishing and upgrading its capacity, research, and 
economic returns that are beneficial to the growth and development of the health sector in 
Bangladesh. 
Table 1: Summary of the comparative pilot study: High-Risk Plaques Identification using 
Coronary Computed Tomography and Computational Fluid Dynamics 
Aspect of the study 
Description 
Study Type 
 Prospective, observational pilot study 
No of subjects 
50 
Objective 
To evaluate the accuracy of this integrated approach in predicting ACS 
events. 

 
 
 
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Study Population 
Inclusion Criteria: 
• Adults aged 40-70 years. 
• Presenting with symptoms of CAD (e.g., chest pain, shortness of 
breath) or having multiple risk factors (e.g., hypertension, 
diabetes, smoking). 
• Able to provide informed consent. 
Exclusion Criteria: 
• Severe renal impairment (due to contrast media risk). 
• Previous allergic reaction to iodinated contrast media. 
• Pregnant or lactating women. 
Baseline Assessment 
• Collect detailed medical history. 
• Perform a physical examination. 
• Conduct initial tests: ECG, blood tests, and echocardiography. 
CCT Imaging 
• Administer beta-blockers if necessary to achieve the target heart 
rate. 
• Perform CCT to acquire high-resolution images of coronary 
arteries. 
• Use iodinated contrast material to enhance imaging. 
Image Analysis and Plaque Identification 
• Reconstruct 3D images of the coronary arteries. 
• Reconstruct 3D images of the coronary arteries. 
CFD Simulation 
• Segment coronary artery regions from CCT images. 
• Generate computational mesh of segmented arteries. 
• Set up CFD simulations with patient-specific boundary 
conditions. 
• Run simulations to calculate hemodynamic parameters (e.g., wall 
shear stress, plaque stress). 
•  
Integration of Data 
• Combine anatomical data from CCT and hemodynamic data 
from CFD. 
• Identify high-risk plaques based on combined anatomical and 
hemodynamic criteria. 
Data Collection and 
Analysis 
• Record all patient data, imaging results, CFD parameters, and 
clinical outcomes. 
• Analyze data to evaluate the accuracy and predictive value of the 
integrated CCT and CFD approach. 
• Identify any practical challenges and limitations encountered 
during the study. 
Ethical 
Considerations 
• Obtain informed consent from all participants. 
• Ensure patient confidentiality and data security. 
• Seek approval from the institutional review board (IRB) or ethics 
committee. 
 
 

 
 
 
16 
 
• Flow Chart:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
General Risk Factors 
High 
Cholesterol 
High Blood Pressure 
Diabetes 
Coronary Artery 
Geometry 
Left Coronary 
artery (LCA) 
Model 
Generation 
Length 
Curvature 
Branching 
Tortuosity 
Proximal LAD 
Distal 
LAD 
Left Main Stem 
(LMS) 
Bifurcation Angle 
Lumen Diameter 
Taguchi Analysis 
S/N Ratio 
Delta Rank 
ANOVA 
% Contribution 
F 
P
Statistical Analysis 

 
 
 
17 
 
• References:  
[1] 
J. M. Lee et al., “Identification of High-Risk Plaques Destined to Cause Acute Coronary 
Syndrome Using Coronary Computed Tomographic Angiography and Computational Fluid 
Dynamics,” Cardiovascular Imaging, vol. 12, no. 6, pp. 1032–1043, Jun. 2019, doi: 
10.1016/J.JCMG.2018.01.023. 
[2] 
W. B. Meijboom et al., “Diagnostic Accuracy of 64-Slice Computed Tomography 
Coronary Angiography. A Prospective, Multicenter, Multivendor Study,” J Am Coll 
Cardiol, vol. 52, no. 25, pp. 2135–2144, 2008, doi: 10.1016/J.JACC.2008.08.058. 
[3] 
J. M. Miller et al., “Diagnostic Performance of Coronary Angiography by 64-Row CT,” 
New England Journal of Medicine, vol. 359, no. 22, pp. 2324–2336, Nov. 2008, doi: 
10.1056/NEJMOA0806576. 
[4] 
A. Sakamoto et al., “Vulnerable Plaque in Patients with Acute Coronary Syndrome: 
Identification, Importance, and Management,” US Cardiology Review, vol. 16, 2022, doi: 
10.15420/USC.2021.22. 
[5] 
“Cardiovascular diseases (CVDs).” Accessed: Jul. 01, 2024. [Online]. Available: 
https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-%28cvds%29 
[6] 
G. A. Mensah, G. A. Roth, and V. Fuster, “The Global Burden of Cardiovascular Diseases 
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20 
 
ANNEXURE - D 
 
Project Title: High-Risk Plaques Identification using Coronary Computed Tomography and 
Computational Fluid Dynamics 
Principal Investigator: 
Dr. Muhammad Tarik Arafat, Professor  
Department of Biomedical Engineering (BME), BUET, Dhaka - 1000, Bangladesh. 
Location: 
Biomechanics lab, Department of Biomedical Engineering (BME), BUET, Dhaka - 1000, Bangladesh. 
Interviewer details: 
The interview will be conducted by study investigators at the lab. 
Purpose of the Study: 
The purpose of the study's current investigation is to assess the initial efficiency and possible application 
of the CCT and CFD in defining the potential high-risk atherosclerotic plague prone to ACS. The critical 
nature of a patient’s plaque can be established during its early formation, and before a particular plaque 
causes an ACS, medication or stent implantation procedure can be taken. This study could be useful in 
refining the way of sorting patients in terms of their potential for subsequent ACS occurrence. Hence, 
studying the composition of plaque and the movement of blood in and around the arteries of atherosclerosis 
enables the researchers to establish the specific predisposing factors toward ACS. Hence, the study 
concentrates on enhancing the techniques of recognizing and interpreting the factors of hazardous plaques 
to avoid progression to ACS, though not provoking it. To determine what technical and clinical issues arose 
within the study and whether logistics were an issue. Thus, the study protocols and methodologies could be 
fine-tuned in the case of subsequent, larger-scale studies. 
Types of participation of the study respondents:  
If you agree to participate in this study, you will be required to provide information on your demographics 
and medical history. 
Duration of study:  
The study will be performed for half an hour. 
Procedures of the study:  
The study concerns the application of imaging and computer modulization to detect high-risk plaques that 
can induce ACS individually. Here's a possible procedure for such a study: Here's a possible procedure for 
such a study: 
 

 
 
 
21 
 
1. Encompass patients with CAD and no recent ACS event, symptomatic CAD who have not had an ACS 
event over the last year. This might be for example for people with chest pain, a family history of CAD, or 
other risk factors. 
2. Undergo CCT scans to check for structural abnormalities in the coronary arteries and the nature of the 
plaque formations. The CCTA images shall be evaluated by the Doctors in the context of risk-indicating 
features which include; Plaque composition, Plaque size & location, and Degree of stenosis in arteries. 
3. Create 3D models of the coronary arteries based on CCT information, and operate using software. 
4. Simulate blood flow through these models to calculate hemodynamic factors like Fractions Flow Reserve 
(FFR), Wall Shear Stress (WSS), and Axial Plaque Stress. 
5. Integrate the results from CCT plaque characteristics and CFD flow analyses. 
6. Determine values that may be considered critical or a switch from normal values for each of the factors 
that characterize high-risk plaques. 
7. Propose a method for risk assessment to divide patients into those with high, moderate, or low risk for 
recurrent ACS. 
Potential benefits: 
The study offers significant potential benefits for both for you and society as a whole. Individually, you 
will receive your gait analysis report which will help the doctors to understand your gait impairments. The 
use of a BWSS ensures your safety during data collection.  
Risks, hazards and discomforts: 
It is imperative to note that the study will incorporate measures to enhance patients’ safety as much as 
possible. Nonetheless, CCT scans use ionizing radiation, though the risk of cancer is very small but 
increases with the number of uses. Though this is a small risk meaning that its likelihood is low in the case 
of having a single scan it does however become slightly high when one has multiple scans. Some of the 
patients who undergo the process of CCT may develop an allergy to the contrast dye to be administered. 
Blockages can sometimes be seen on CCT scans even though they are not large enough to create symptoms. 
Thus, it can cause additional stress and may lead to additional and perhaps unjustified diagnostic and 
treatment steps. We also know that CFD is a computer modeling technique and that the results reclaimed 
hinge on the CCT scan input data and the assumptions put to the model. About any kind of test or operation, 
it is natural for individuals to feel anxious, especially when there is an issue of coronary artery disease. 
Reimbursements: 
Neither will you be reimbursed for any medical costs. Nevertheless, if any health risk occurs because of 
studying participation, appropriate measures will be provided by the study researchers. Once more, if you 
cannot pay for the travel cost and at the same time attend the study session, reimbursement will be provided 
for the cost. This compensation will be made after your involvement as a participant in this study is 
complete. 

 
 
 
22 
 
Confidentiality: 
The confidentiality of about your information will be rigorously maintained throughout the study. Personal 
identifying information will be collected from you initially for contact but will be removed from the dataset 
after data collection to ensure anonymity. You will be assigned a unique identification code, which will be 
used in all data analysis and reporting. 
Rights to withdraw from participation: 
Participation in this study is voluntary and you may withdraw from the study for any reason at any time. 
You will not be penalized in any way for declining to take part in or withdrawing from the study. If you 
decide to withdraw, the gait data collection procedure will be discontinued. 
 
 
 
I am consciously and voluntarily participating in the above research study entitled “High-Risk Plaques 
Identification using Coronary Computed Tomography and Computational Fluid Dynamics”. I 
understand that I will not be given any financial benefit for my participation. The doctors assured me that 
participating in this study would not harm me physically or mentally and that at any time I would be able 
to voluntarily withdraw from the study and my treatment would not affect it. All my information will be 
kept confidential. 
[Photographing / Video recording] 
Photographing of a participant will be used to visualize experimental setups for the purposes including 
publication, grant application and public relations. Private information such as the participant’s name will 
not be made available. 
 
Do you agree with Photographing during the experiment? 
 
 
 
 
 
Yes 
 
 
No 
 
During any part of the experiment, whenever participants feel discomforts beyond tolerance, trials can be 
stopped. 

 
 
 
23 
 
Name of participant:  
 
 
Signature/Thumb print of the participant:  
Name of the witness:  
Signature of the witness:  
Name of the interviewer: 
Signature of the interviewer: 
[*please note: Where the participant/s are aged under 18, separate parental consent is required; 
where the participant/s are unable to answer for themselves due to disability, parental or guardian 
consent may be required.] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
24 
 
INFORMED CONSENT FORM  
(English Version) 
High-Risk Plaques Identification using Coronary Computed Tomography and 
Computational Fluid Dynamics 
I am giving consent to take part in the above-mentioned research study of Department of Biomedical 
Engineering, BUET. The nature of the research has been explained to me. 
 
I am ensuring that, 
 
I am taking part in this study voluntarily …………………….     Yes         No 
 
I am voluntarily giving my time to the research ….………….     Yes         No 
 
I am giving my permission to let the researchers  
of BME, BUET to keep the consent form as rec ………………   Yes        No 
 
 
and I have been allowed to ask questions about this study and my participation in it. I understand that all 
my personal information will be kept confidential, and no part of this information that might reveal my 
identity will be published. I also understand that I can refuse to take part in this study any time I want, 
and I will not be accounted for any questioning or harm for my refusal. 
 
 
Name of Participant ……………………    Sign of Participant ………………………. 
 
Name of Investigator …………………..    Sign of Investigator ……………………… 
 
Date.................... 
 
[*please note: If the participants are unable to answer for themselves due to disability, guardian 
consent may be required.] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
25 
 
Case Report Form 
Project Title: High-Risk Plaques Identification using Coronary Computed Tomography and 
Computational Fluid Dynamics 
 
Patients Characteristics 
Age (years) 
 
Male gender 
 
Heart Rate (bpm) 
 
Median interval between coronary 
CTA and ACS 
 
LVEF(%) 
 
 
Presence of 
Ruptured plaques 
Absence of 
Ruptured plaques 
P 
value 
Cardiovascular risk factors 
Diabetes mellitus 
 
 
 
Hypertension 
 
 
 
Dyslipidemia 
 
 
 
Current smoker 
 
 
 
Previous Myocardial Infection 
 
 
 
Clinical presentation 
NSTEMI 
 
 
 
STEMI 
 
 
 
Unstable angina 
 
 
 
Coronary CTA characteristics 
Minimal Lumen area, mm2 
 
 
 
Diameter stenosis, % 
 
 
 

 
 
 
26 
 
Distance from coronary ostium to 
MLA, mm 
 
 
 
Lesion length, mm 
 
 
 
Coronary CTA acquisition 
Heart rate (beats/min) 
 
 
 
Prospective acquisition 
 
 
 
Retrospective acquisition 
 
 
 
Lesion characteristics 
Lesion locations 
 
 
 
Left main to LAD 
 
 
 
LCx 
 
 
 
RCA 
 
 
 
Quantitative coronary angiography 
Reference vessel diameter (mm) 
 
 
 
Minimal lumen diameter (mm) 
 
 
 
Diameter stenosis (%) 
 
 
 
Lesion length (mm) 
 
 
 
Laboratory data 
Creatinine (mg/dl) 
 
 
 
eGFR (ml/min/1.73 m2) 
 
 
 
HbAlc (%) 
 
 
 
Total-Cholesterol (mg/dl) 
 
 
 
HDL-Cholesterol (mg/dl) 
 
 
 
LDL-Cholesterol (mg/dl) 
 
 
 

 
 
 
27 
 
Uremic Acid (mg/dl) 
 
 
 
CT findings 
Radius of arch curvature(mm) 
 
 
 
Aortic arch center lumen line 
length (mm) 
 
 
 
Aortic arch tortuosity index 
 
 
 
Diameter of proximal aortic arch 
(mm) 
 
 
 
Diameter of distal aortic arch 
(mm) 
 
 
 
Maximum diameter of aortic arch 
(mm) 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
28 
 
ANNEXURE - E 
 
o 
Total Budget:- 80,000/- TK 
o Detailed Budget:- 
1.  
Personnel Cost: N/A 
2. 
Field Expenses/Laboratory Cost:- 2,000/- TK 
3.  
Supplies and Materials (Items & quantity to be specified): Included with Patients 
cost 
4.  
Patient Cost (If applicable):-  
Patients for CT (10) 
Doppler ultrasound (2) 
FFR (1) 
45,000 TK 
5,000 TK 
25,000 TK 
 
5.  
Travel Cost (Internal travel cost only):- 2,000/- TK 
6.  
Office Stationery (Items & quantity to be specified): N/A 
7.  
Data Processing/Computer Charges (If applicable) : N/A 
8.  
Printing and Reproduction:- 500/- TK 
9.  
Contractual Services (Other than manpower): N/A 
10.  Miscellaneous:-  500/- TK