Coronary DiseaseNCT02237456
DOCTOR Compare - A Study in the "DOCTOR" Series (Does Optical Coherence Tomography Optimize Revascularization?"
An observational study of Coronary Disease and Myocardial Infarction, run by Aarhus University Hospital Skejby at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Myocardial Infarction, Atherosclerosis
- What is being tested?
- Comparison of OCT scans and Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 2 sitesDenmark
- Study dates
- Jul 2014to Sep 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Indication for intervention with PCI on the right or left coronary artery
- Age >18 years
- Must be able to give written informed consent
Who cannot join
- Expected life span of less than one year
- Pregnancy or possible pregnancy
- Cardiogenic shock
- Especially tortuous vessels
- Renal impairment (creatinine> 100 micromoles / L)
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus N, Denmark, 8200
Rigshospitalet
Copenhagen, 2100
About this study
Official title: Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare
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.
Read the 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.
- Conditions
- Coronary Disease, Myocardial Infarction, Atherosclerosis
- Being tested
- Comparison of OCT scans, Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare
- Keywords
- Myocardial infarction, Atherosclerosis, PCI, OCT, Optical coherence tomography, Stent, Bioresorbable stents
- Medical subject headings
- Coronary Disease, Myocardial Infarction, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of OCT scansProcedure or surgery
Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR CompareProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images
Measured: Baseline
Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)
Measured: Baseline
Characteristics of fibrous tissue (maximum scan penetrance)
Measured: Baseline
Characteristics of lipid plaque (signal intensities under the fibrous cap)
Measured: Baseline
Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)
Measured: Baseline
Characteristics of vessel dissection (exploratory)
Measured: Baseline
Characteristics of the fibrous cap (minimum thickness)
Measured: Baseline
Secondary outcomes (1)
Detection of stent struts
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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Ramsing Holm, Aarhus University Hospital Skejby
- Investigators
- Niels R Holm, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237456
- Sponsor's protocol ID
- 1-10-72-59-14
- Status last verified
- Mar 2015
- First submitted
- 24 Jun 2014
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare
- ClinicalTrials.gov ID
- NCT02237456
- Acronym / sponsor ID
- 1-10-72-59-14
- Conditions
- Coronary Disease, Myocardial Infarction, Atherosclerosis
- Keywords
- Myocardial infarction, Atherosclerosis, PCI, OCT, Optical coherence tomography, Stent, Bioresorbable stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Indication for intervention with PCI on the right or left coronary artery
- Age >18 years
- Must be able to give written informed consent
Key exclusion criteria (5 listed)
- Expected life span of less than one year
- Pregnancy or possible pregnancy
- Cardiogenic shock
- Especially tortuous vessels
- Renal impairment (creatinine> 100 micromoles / L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of OCT scans | Procedure or surgery | – |
| Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare | Procedure or surgery | – |
Primary outcome
Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images
Time frame: Baseline
Characteristics of thrombic mass (average thickness of signal-rich area, shade degree)
Time frame: Baseline
Characteristics of fibrous tissue (maximum scan penetrance)
Time frame: Baseline
Characteristics of lipid plaque (signal intensities under the fibrous cap)
Time frame: Baseline
Characteristics of calcium plaque (matched calcium plaques that can be quantified for sizes)
Time frame: Baseline
Characteristics of vessel dissection (exploratory)
Time frame: Baseline
Characteristics of the fibrous cap (minimum thickness)
Time frame: Baseline
1 secondary outcome
Detection of stent struts
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels R Holm, MD principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Myocardial Infarction, run by Aarhus University Hospital Skejby at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of quantitative and semi-quantitative tissue analysis obtained with OCT images (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.