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Completed

NCT Number: NCT02618473

Effect of Snapshot Freeze on Cardiac CT Image Quality

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medical Research, OUH, Svendborg

Svendborg, 5700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age ≥ 18 years,
  • glomerular filtration rate ≥ 60 mL/min,
  • heart rate between 60 and 85 bpm before the scan

Exclusion criteria

  • irregular heart rhythm
  • history of allergic reaction to contrast agents

Treatment and study plan

non-seloken

Other

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.

Primary outcomes

  1. images with non diagnostic image quality

    Time frame: up to 1 year

    number of non diagnostic images.

Secondary outcomes

  1. images with Excellent image quality

    Time frame: up to 1 year

    number of presented images with "Excellent" image quality

  2. motion artifacts

    Time frame: up to 1 year

    number of presented motion artifacts

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Impact of a Motion Correction Algorithm on Image Quality and Diagnostic Utility in Patients Undergoing CT Angiography: A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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