DOCTOR Compare - A Study in the "DOCTOR" Series (Does Optical Coherence Tomography Optimize Revascularization?"
Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Metallic Stents and Bioresorbable Vascular Scaffolds - DOCTOR Compare
1 other identifier
observational
11
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2014
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 11, 2014
CompletedMarch 13, 2015
March 1, 2015
2 months
June 24, 2014
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Characteristics of the fibrous cap (minimum thickness)
Baseline
Secondary Outcomes (1)
Detection of stent struts
Baseline
Interventions
Eligibility Criteria
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.
You may qualify if:
- Indication for intervention with PCI on the right or left coronary artery
- Age \>18 years
- Must be able to give written informed consent
You may not qualify if:
- Expected life span of less than one year
- Pregnancy or possible pregnancy
- Cardiogenic shock
- Especially tortuous vessels
- Renal impairment (creatinine\> 100 micromoles / L)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aarhus University Hospital
Aarhus N, Denmark, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Niels R Holm, MD
Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 24, 2014
First Posted
September 11, 2014
Study Start
July 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
March 13, 2015
Record last verified: 2015-03