Visualisation of disease progression in human coronary arteries and the relationship with biomechanical forces

Imaging and Modeling to investigate the mutual relationship of plaque growth and biomechanical parameters in human coronary arteries

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN43170100

Enrollment

Registered

2020-07-07

Start date

2016-03-03

Completion date

Unknown

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute coronary syndrome Circulatory System

Interventions

This study is an observational study on atherosclerotic plaque progression in human coronary arteries. The aim of this study is to investigate the influence of biomechanical factors on plaque progress

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient eligible for PCI of a native coronary artery 2. Written informed consent obtained 3. Study coronary artery must be accessible to the OCT /NIRS-IVUS catheters

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent 2. Under 18 years of age 3. Hemodynamic instability 4. Cardiogenic shock 5. TIMI 0 flow at target lesion site 6. Lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot transverse 7. Bypass graft as target vessel 8. Ejection fraction less than 30% 9. Contra-indication to emergency coronary artery bypass surgery 10. No access to cardiac surgery 11. Contra-indication to treatment with aspirin, ticlopidine, clopidogrel, prasugrel, ticagrelor, or heparin 12. Renal insufficiency (creatinine clearing < 50ml/min) 13. Pregnancy or inadequate anticonception 14. History of bleeding diathesis or coagulopathy. 15. History of stroke within the past year 16. History of significant gastrointestinal bleed within the past month

Design outcomes

Primary

Measure	Time frame
1. Shear stress measured using computational fluid dynamics in 3D reconstructions of the coronary arteries based on the imaging at baseline and categorized as low, mid or high at baseline and 1 year 2. Plaque geometry and composition (including wall thickness, cap thickness and lipids) measured at several locations in the coronary arteries using images acquired and compared for regions exposed to low, mid and high shear stress at baseline and 1 year	—

Measure

Time frame

1. Shear stress measured using computational fluid dynamics in 3D reconstructions of the coronary arteries based on the imaging at baseline and categorized as low, mid or high at baseline and 1 year 2. Plaque geometry and composition (including wall thickness, cap thickness and lipids) measured at several locations in the coronary arteries using images acquired and compared for regions exposed to low, mid and high shear stress at baseline and 1 year

—

Secondary

Measure	Time frame
Stress inside the wall will be calculated using finite element modelling based on the images acquired at baseline and 1 year follow up	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026