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

Completed

Conditions: atherosclerosis / arteriosclerotic vascular disease
10011082

Registration Number: NL-OMON43580

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

* Patient eligible for PCI of a native coronary artery
* Written informed consent obtained
* Study coronary artery must be accessible to the OCT /NIRS-IVUS catheters;

Exclusion Criteria

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary endpoints to be investigated:<br /><br>1) Association between shear stress at baseline and plaque geometry and<br /><br>composition at baseline (including wall thickness, cap thickness and lipids).<br /><br>2) Association between shear stress at baseline and plaque geometry and<br /><br>composition changes over time in (including wall thickness, cap thickness and<br /><br>lipids). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Association between change in plaque geometry and composition (e.g. wall<br /><br>thickness, cap thickness and lipids) and wall stress changes.<br /><br>2) Association between change in plaque geometry and composition (including<br /><br>wall thickness, cap thickness and lipids) and change in shear stress. </p><br>