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

Not Applicable

Completed

• Conditions: Acute coronary syndrome; Circulatory System

• Registration Number: ISRCTN43170100
• Lead Sponsor: Erasmus University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-04-17
• Study Start: 2020-07-07
• Last Update Posted: 17 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br>

Secondary Outcome Measures

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