Geometrical Influences on Atherosclerosis and Blood Flow

NCT07002697 | Recruiting

• 1 other identifier: BUET/ERC/2024/04
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Atherosclerosis and Blood Flow in Coronary Artery

Keywords

Computational Fluid Dynamics (CFD); Design Of Experiment (DOE); Computed Tomography (CT); Acute Coronary Syndrome (ACS)

Outcome Measures

Primary Outcomes (1)

• 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.

  Each patient is monitored for upto 1 year after enrollment to assess plaque changes and hemodynamics via periodic imaging and analysis.

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Severe renal impairment (due to contrast media risk).
• Previous allergic reaction to iodinated contrast media.
• Pregnant or lactating women.

Sponsors & Collaborators

• Bangladesh University of Engineering and Technology: lead
• National Institute of Cardiovascular Diseases, Bangladesh: collaborator

Study Sites (1)

National Institute of Cardiovascular Disease (NICVD)

Dhaka, 1207, Bangladesh

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Study Officials

• Muhammad Tarik Arafat, PhD

  Department of Biomedical Engineering, Bangladesh University of Engineering and Technology (BUET), Dhaka - 1205

  PRINCIPAL INVESTIGATOR

• Dr. M G Azam, MBBS, MD, FSCAI

  NICVD, Dhaka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Tarik Arafat, PhD

CONTACT

01911764467; tarikarafat@bme.buet.ac.bd

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

CONTACT

01623965702; siam.ahmed.bme.buet@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: June 3, 2025
• Study Start: August 10, 2024
• Primary Completion: October 11, 2025
• Study Completion: April 11, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

BA (1)