Atherosclerosis, Coronary Disease, Myocardial Infarction
Conditions
Keywords
Myocardial infarction, Atherosclerosis, PCI, OCT, Optical coherence tomography, Stent, Bioresorbable stents
Brief summary
The purpose of this study is to compare optical coherence tomography (OCT) scans performed in the same coronary artery with two different OCT systems (Lunawave and OPTIS) before and after implantation of stents or bioresorbable scaffolds.
Detailed description
Standard treatment of persons with narrowings of the heart's coronary artery is balloon treatment with implantation of stents (Percutaneous coronary intervention (PCI )). To evaluate disease in coronary arteries prior to, and during PCI , X-ray fluoroscopy with contrast is used. X-ray fluoroscopy produces little information of any disease changes in the vessel wall and implanted stents and especially polylactid acid (PLA) type bioresorbable scaffolds are visualized poorly . Optical coherence tomography (OCT) is a light-based, high resolution, imaging modality for intra coronary assessment of tissue and implants. Currently two CE-marked OCT systems are used in clinical practice in (Illumien OPTIS, St. Jude Medical , Minnesota, USA and Lunawave, Terumo , Tokyo, Japan). It is a common assumption that the scanning images for the two systems are similar and are interpreted the same way. The aim of the study is to assess if tissue, stents and PLA type scaffolds are presented with same characteristics by the two systems. Same segment scans by the two systems will be systematically compared and reported. Differences in scans by the two systems may have implications for the interpretation and thus may affect clinical decisions.
Interventions
PROCEDUREComparison of OCT scans
PROCEDUREComparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare
Sponsors
Aarhus University Hospital Skejby
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for intervention with PCI on the right or left coronary artery * Age \>18 years * Must be able to give written informed consent
Exclusion criteria
* Expected life span of less than one year * Pregnancy or possible pregnancy * Cardiogenic shock * Especially tortuous vessels * Renal impairment (creatinine\> 100 micromoles / L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characteristics of the fibrous cap (minimum thickness) | Baseline |
| Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images | Baseline |
| Characteristics of thrombic mass (average thickness of signal-rich area, shade degree) | Baseline |
| Characteristics of fibrous tissue (maximum scan penetrance) | Baseline |
| Characteristics of lipid plaque (signal intensities under the fibrous cap) | Baseline |
| Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes) | Baseline |
| Characteristics of vessel dissection (exploratory) | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of stent struts | Baseline | Stent evaluation obtained by Lunawawe recordings versus OPTIS recordings (including areas with thrombus, plaque, bare metal stent, bioresorbable stents, 3D reconstruction of stents (qualitative and quantitative assessment of stent visualization degree) |
Countries
Denmark
Outcome results
None listed