Effect of Snapshot Freeze on Cardiac CT Image Quality

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02618473
Collaborator
(none)
140
1
2
30.9
4.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: non-seloken
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of a Motion Correction Algorithm on Image Quality and Diagnostic Utility in Patients Undergoing CT Angiography: A Randomized Controlled Trial
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 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.

Experimental: non-seloken

Patients randomized to "non-seloken", do not receive any medication.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. images with non diagnostic image quality [up to 1 year]

    number of non diagnostic images.

Secondary Outcome Measures

  1. images with Excellent image quality [up to 1 year]

    number of presented images with "Excellent" image quality

  2. motion artifacts [up to 1 year]

    number of presented motion artifacts

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Medical Research, OUH, Svendborg Svendborg Denmark 5700

Sponsors and Collaborators

  • Odense University Hospital

Investigators

  • Study Director: jess Lambrechtsen, MD, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hussam Mahmoud Sheta, M.D, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT02618473
Other Study ID Numbers:
  • Snapshot Freeze
First Posted:
Dec 1, 2015
Last Update Posted:
Dec 4, 2015
Last Verified:
Nov 1, 2015
Keywords provided by Hussam Mahmoud Sheta, M.D, Odense University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2015