Heart Diseases Clinical Trial
Official title:
Impact of a Motion Correction Algorithm on Image Quality and Diagnostic Utility in Patients Undergoing CT Angiography: A Randomized Controlled Trial
The aim of this study was to investigate the effect of a new motion correction algorithm on image quality and diagnostic utility in unselected patients undergoing coronary cardiac computed tomography, and to investigate if this motion correction algorithm can compensate for the usual use of intravenously medication (beta-blockers) before the scan.
Aims:
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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