Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2013-01-31
2015-08-31
Brief Summary
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Detailed Description
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To investigate the motion correction algorithm Snapshot-Freeze(SSF) compared to standard reconstruction(STD) in patients randomized to receive beta-blockers(BB) or no beta-blockers(non-BB) before coronary CT angiography (CCTA), and to investigate if SSF can replace BB.
Methods:
The study included 140 consecutively recruited patients scheduled to CCTA to rule out coronary artery disease.
The inclusion criteria were: age ≥ 18 years, Glomerular filtration rate ≥ 60 mL/min, Heart Rate between 60 and 85 bpm before the scan. The exclusion criteria were: irregular heart rhythm or history of allergic reaction to contrast agents. Patients were randomized to the BB group or the non-BB group. The trial complied with the Declaration of Helsinki and was approved by the local ethics committee. Written informed consent was obtained from all patients.
Image quality score:
The evaluation was performed according to the Likert score as follows: 1: excellent, no motion artifacts, clear delineation of the segments; 2: good, minor artifacts, mild blurring of the segment; 3: adequate, moderate artifacts, moderate blurring without structure discontinuity; and 4: poor and non-diagnostic, with doubling or discontinuity in the course of the segments, preventing evaluation or producing vessel structures that were not differentiable. In cases where the image quality was less than excellent (Likert score 2-4), the readers noted the reason(s) for the observed artifact.
Statistical analyses:
Quantitative variables were expressed as mean ± standard deviation, and categorical values as frequencies or percentages. Values from the Likert score were dichotomized to excellent vs. non-excellent (Likert score 1 vs. 2-4), and diagnostic vs. non-diagnostic (Likert score 1-3 vs. 4). McNemar's test was performed to test categorical variables separately per-vessel and per-patient level. Analyses for all segments were calculated by the Wilcoxon signed-rank test.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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non-seloken
Patients randomized to "non-seloken", do not receive any medication.
non-seloken
regarding the guidelines patients receive seloken before the cardiac CT scan to lower the heart rate during the scan. The intervention in this study is to avoid the medication with seloken before the scan, and to investigate if the use of a new motion correction scan algorithm can compensate for the absence of the seloken.
seloken
In "seloken" arm, patients performs the cardiac CT procedure regarding the national scan guidelines, ande receive 5-10 intravenous seloken, until heart rate below 60 beats pr minit is achieved.
No interventions assigned to this group
Interventions
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non-seloken
regarding the guidelines patients receive seloken before the cardiac CT scan to lower the heart rate during the scan. The intervention in this study is to avoid the medication with seloken before the scan, and to investigate if the use of a new motion correction scan algorithm can compensate for the absence of the seloken.
Eligibility Criteria
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Inclusion Criteria
* glomerular filtration rate ≥ 60 mL/min,
* heart rate between 60 and 85 bpm before the scan
Exclusion Criteria
* history of allergic reaction to contrast agents
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Hussam Mahmoud Sheta
M.D
Principal Investigators
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jess Lambrechtsen, MD
Role: STUDY_DIRECTOR
Odense University Hospital
Locations
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Department of Medical Research, OUH, Svendborg
Svendborg, Svendborg, Denmark
Countries
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Other Identifiers
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Snapshot Freeze
Identifier Type: -
Identifier Source: org_study_id