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NCT Number: NCT07002697

Geometrical Influences on Atherosclerosis and Blood Flow

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Cardiovascular Disease (NICVD)

Dhaka, 1207, Bangladesh

Location status: Recruiting

Location contact

Dr. M G Azam, MBBS,MD,FSCAI

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Md. Siam Ahmed Nishat, B.Sc. in ENgineering

CONTACT

[email protected]

01623965702

Muhammad Tarik Arafat, PhD

CONTACT

[email protected]

01911764467

Sponsors and collaborators

Lead sponsor

Bangladesh University of Engineering and Technology

Other

Collaborators

  • National Institute of Cardiovascular Diseases, Bangladesh

Registry information

Official study title

High-Risk Plaques Identification Using Coronary Computed Tomography and Computational Fluid Dynamics

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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