NCT02618473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Last Updated

December 4, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 18, 2015

Last Update Submit

December 3, 2015

Conditions

Heart Diseases

Keywords

Coronary computed tomography angiographymotion artifactsmotion correction algorithmdiagnostic utility

Outcome Measures

Primary Outcomes (1)

  • images with non diagnostic image quality

    number of non diagnostic images.

    up to 1 year

Secondary Outcomes (2)

  • images with Excellent image quality

    up to 1 year

  • motion artifacts

    up to 1 year

Study Arms (2)

seloken

NO INTERVENTION

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.

non-seloken

EXPERIMENTAL

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

Other: non-seloken

Interventions

non-selokenOTHER

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.

non-seloken

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, OUH, Svendborg

Svendborg, Svendborg, 5700, Denmark

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • jess Lambrechtsen, MD

    Odense University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D

Study Record Dates

First Submitted

November 18, 2015

First Posted

December 1, 2015

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

August 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-11

Locations

DK(1)