Atherosclerosis and Blood Flow in Coronary ArteryNCT07002697
Geometrical Influences on Atherosclerosis and Blood Flow
An observational study of Atherosclerosis and Blood Flow in Coronary Artery, run by Bangladesh University of Engineering and Technology at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis and Blood Flow in Coronary Artery
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- 10 Aug 2024to 11 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population includes patients diagnosed with atherosclerosis, identified through CT angiography (CTA). High-resolution CT scan data reconstruct patient-specific vascular geometries, focusing on regions of clinical interest, such as arterial bifurcations and stenotic segments. Key parameters include Curvature, Surface Roughness, stenosis severity and bifurcation angles, allowing for a detailed computational fluid dynamics (CFD) analysis of hemodynamic forces contributing to endothelial dysfunction and plaque progression.
Who may be able to join
- 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.
Who cannot join
- Severe renal impairment (due to contrast media risk).
- Previous allergic reaction to iodinated contrast media.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
National Institute of Cardiovascular Disease (NICVD)
Dhaka, 1207
Dr. M G Azam, MBBS,MD,FSCAI
About this study
Official title: High-Risk Plaques Identification Using Coronary Computed Tomography and Computational Fluid Dynamics
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 integrating Coronary Computed Tomography (CCT) with Computational Fluid Dynamics (CFD) to provide detailed insights into plaque characteristics and their hemodynamic environment.
The study's primary aim 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 non-invasive hemodynamic assessment to identify high-risk plaques destined to cause acute coronary syndrome. Patients with adverse plaque characteristics like positive remodeling or low-attenuation plaque have a greater risk of future coronary events.
Read the detailed description
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 a proper rate of heartbeat. The order includes checking the patient's habits for proper hydration and contraindications to the use of contrast media. If investigators 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 that were 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 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 velocity, 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), 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). Identify high-risk plaques based on combined criteria, including anatomical vulnerability and hemodynamic stress. Then, the investigators Generate a detailed report summarizing the findings from CCT and CFD analysis. The investigators Stratify patients into different risk categories (low, moderate, high) based on the comprehensive assessment. Finally, the investigators will adjust the treatment plan based on the findings and analysis of the patient's response.
- Keywords
- Computational Fluid Dynamics (CFD), Design Of Experiment (DOE), Computed Tomography (CT), Acute Coronary Syndrome (ACS)
- Medical subject headings
- Atherosclerosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People who have Acute Coronary Syndrome and did a CT angiogram | In observational studies aimed at identifying high-risk plaques using coronary computed tomography (CT) and computational fluid dynamics (CFD), the group or cohort typically consists of people having diagnostic imaging for suspected or established coronary artery disease (CAD). Participants are frequently chosen based on clinical indicators such as chest discomfort, a history of myocardial infarction, or abnormal stress test findings. Cohort characteristics include age, gender, cardiovascular risk factors (such as hypertension, diabetes, hyperlipidaemia, and smoking), and previous CAD therapies. The study will examine plaque features (e.g., low-attenuation plaques, positive remodelling) and hemodynamic parameters generated from CFD (e.g., wall shear stress, pressure gradients) to stratify risk. Detailed demographic, clinical, and imaging data are collected to examine relationships between plaque features and cardiovascular outcomes, ensuring a thorough analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometrical Influences on Atherosclerosis and Blood Flow: A Computational Fluid Dynamics and Experimental Design Approach
The primary outcome of this study is the focus on evaluating the impact of vascular geometry on blood flow patterns and their role in the development of atherosclerosis. Using Computational Fluid Dynamics (CFD) simulations, the study investigates critical hemodynamic factors, such as wall shear stress, pressure gradients, and recirculation zones, which are influenced by variations in vessel geometry. By integrating experimental data with computational models, the study aims to identify specific geometrical features that contribute to plaque formation and progression, ultimately enhancing the understanding of atherosclerosis and guiding targeted interventions.
Measured: Each patient is monitored for upto 1 year after enrollment to assess plaque changes and hemodynamics via periodic imaging and analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start10 Aug 2024
- Primary completion11 Oct 2025 (estimated)
- Study completion11 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis and Blood Flow in Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh University of Engineering and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Cardiovascular Diseases, Bangladesh
- Responsible party
- Principal investigator, Muhammad Tarik Arafat, Bangladesh University of Engineering and Technology
- Investigators
- Muhammad Tarik Arafat, PhD, Principal investigator, Department of Biomedical Engineering, Bangladesh University of Engineering and Technology (BUET), Dhaka - 1205Dr. M G Azam, MBBS, MD, FSCAI, Principal investigator, NICVD, Dhaka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002697
- Sponsor's protocol ID
- BUET/ERC/2024/04
- Status last verified
- May 2025
- First submitted
- 19 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Risk Plaques Identification Using Coronary Computed Tomography and Computational Fluid Dynamics
- ClinicalTrials.gov ID
- NCT07002697
- Acronym / sponsor ID
- BUET/ERC/2024/04
- Keywords
- Computational Fluid Dynamics (CFD), Design Of Experiment (DOE), Computed Tomography (CT), Acute Coronary Syndrome (ACS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bangladesh University of Engineering and TechnologyUniversity, hospital or other
- Collaborators
- National Institute of Cardiovascular Diseases, Bangladesh
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 11 Oct 2025 (estimated)
- Study completion
- 11 Apr 2026 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 integrating Coronary Computed Tomography (CCT) with Computational Fluid Dynamics (CFD) to provide detailed insights into plaque characteristics and their hemodynamic environment.
The study's primary aim 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 non-invasive hemodynamic assessment to identify high-risk plaques destined to cause acute coronary syndrome. Patients with adverse plaque characteristics like positive remodeling or low-attenuation plaque have a greater risk of future coronary events.
Detailed description
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 a proper rate of heartbeat. The order includes checking the patient's habits for proper hydration and contraindications to the use of contrast media. If investigators 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 that were 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 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 velocity, 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), 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). Identify high-risk plaques based on combined criteria, including anatomical vulnerability and hemodynamic stress. Then, the investigators Generate a detailed report summarizing the findings from CCT and CFD analysis. The investigators Stratify patients into different risk categories (low, moderate, high) based on the comprehensive assessment. Finally, the investigators will adjust the treatment plan based on the findings and analysis of the patient's response.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People who have Acute Coronary Syndrome and did a CT angiogram | – | –In observational studies aimed at identifying high-risk plaques using coronary computed tomography (CT) and computational fluid dynamics (CFD), the group or cohort typically consists of people having diagnostic imaging for suspected or established coronary artery disease (CAD). Participants are frequently chosen based on clinical indicators such as chest discomfort, a history of myocardial infarction, or abnormal stress test findings. Cohort characteristics include age, gender, cardiovascular risk factors (such as hypertension, diabetes, hyperlipidaemia, and smoking), and previous CAD therapies. The study will examine plaque features (e.g., low-attenuation plaques, positive remodelling) and hemodynamic parameters generated from CFD (e.g., wall shear stress, pressure gradients) to stratify risk. Detailed demographic, clinical, and imaging data are collected to examine relationships between plaque features and cardiovascular outcomes, ensuring a thorough analysis. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients diagnosed with atherosclerosis, identified through CT angiography (CTA). High-resolution CT scan data reconstruct patient-specific vascular geometries, focusing on regions of clinical interest, such as arterial bifurcations and stenotic segments. Key parameters include Curvature, Surface Roughness, stenosis severity and bifurcation angles, allowing for a detailed computational fluid dynamics (CFD) analysis of hemodynamic forces contributing to endothelial dysfunction and plaque progression.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Severe renal impairment (due to contrast media risk).
- Previous allergic reaction to iodinated contrast media.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Geometrical Influences on Atherosclerosis and Blood Flow: A Computational Fluid Dynamics and Experimental Design Approach
Time frame: Each patient is monitored for upto 1 year after enrollment to assess plaque changes and hemodynamics via periodic imaging and analysis.
The primary outcome of this study is the focus on evaluating the impact of vascular geometry on blood flow patterns and their role in the development of atherosclerosis. Using Computational Fluid Dynamics (CFD) simulations, the study investigates critical hemodynamic factors, such as wall shear stress, pressure gradients, and recirculation zones, which are influenced by variations in vessel geometry. By integrating experimental data with computational models, the study aims to identify specific geometrical features that contribute to plaque formation and progression, ultimately enhancing the understanding of atherosclerosis and guiding targeted interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Tarik Arafat, PhD principal investigator
Department of Biomedical Engineering, Bangladesh University of Engineering and Technology (BUET), Dhaka - 1205
Dr. M G Azam, MBBS, MD, FSCAI principal investigator
NICVD, Dhaka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Blood Flow in Coronary Artery, run by Bangladesh University of Engineering and Technology at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Tarik Arafat, PhD (01911764467, tarikarafat@bme.buet.ac.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometrical Influences on Atherosclerosis and Blood Flow: A Computational Fluid Dynamics and Experimental Design Approach (time frame: Each patient is monitored for upto 1 year after enrollment to assess plaque changes and hemodynamics via periodic imaging and analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.