Clinical trial NCT02237456: DOCTOR Compare - A Study in the "DOCTOR" Series (Does Optical Coherence Tomography Optimize Revascularization?"
Official title: Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Myocardial Infarction
Atherosclerosis
Keywords: Myocardial infarction
Atherosclerosis
PCI
OCT
Optical coherence tomography
Stent
Bioresorbable stents
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing percutaneous coronary intervention (PCI) at Department of Cardiology, Aarhus University Hospital Skejby, will be invited to participate in the study. 12 patients will be included; 4 with acute ST-elevation myocardial infarct (STEMI) and 8 stable or stabilized patients.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images
timeFrame: Baseline
measure: Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)
timeFrame: Baseline
measure: Characteristics of fibrous tissue (maximum scan penetrance)
timeFrame: Baseline
measure: Characteristics of lipid plaque (signal intensities under the fibrous cap)
timeFrame: Baseline
measure: Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)
timeFrame: Baseline
measure: Characteristics of vessel dissection (exploratory)
timeFrame: Baseline
measure: Characteristics of the fibrous cap (minimum thickness)
timeFrame: Baseline
Secondary outcomes:
measure: Detection of stent struts
timeFrame: Baseline
Other outcomes:
Locations:
city: Aarhus N, Denmark
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Aarhus University Hospital
name: Niels R Holm, MD
role: PRINCIPAL_INVESTIGATOR
References: