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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43580
Enrollment
70
Registered
2015-11-03
Start date
2016-03-02
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

atherosclerosis / arteriosclerotic vascular disease

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Our primary endpoints to be investigated: 1) Association between shear stress at baseline and plaque geometry and composition at baseline (including wall thickness, cap thickness and lipids). 2) Association between shear stress at baseline and plaque geometry and composition changes over time in (including wall thickness, cap thickness and lipids).

Secondary

MeasureTime frame
1) Association between change in plaque geometry and composition (e.g. wall thickness, cap thickness and lipids) and wall stress changes. 2) Association between change in plaque geometry and composition (including wall thickness, cap thickness and lipids) and change in shear stress.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)