Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY (VICTORY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by MDDX LLC
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
MDDX LLC
ClinicalTrials.gov Identifier:
NCT01856504
First received: May 15, 2013
Last updated: October 28, 2013
Last verified: October 2013

May 15, 2013
October 28, 2013
May 2013
May 2015   (final data collection date for primary outcome measure)
  • Diagnostic Accuracy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To compare the per-patient, per-vessel and per-segment diagnostic accuracy of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
  • Diagnostic Interpretability [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To compare the per-patient, per-vessel and per-segment diagnostic interpretability of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
  • Image quality [ Time Frame: 30 day ] [ Designated as safety issue: No ]
    To compare the per-patient, per-vessel and per-segment quantitative image quality of CCTA with SSF to conventional CCTA, as compared to invasive quantitative coronary angiography.
Same as current
Complete list of historical versions of study NCT01856504 on ClinicalTrials.gov Archive Site
  • Upper threshold of heart rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    To determine the upper threshold of heart rate below which CCTA with SSF is most effective.
  • incremental & additive value [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    To determine the incremental & additive value of SSF to conventional CCTA for diagnostic accuracy / diagnostic interpretability / image quality.
Same as current
Not Provided
Not Provided
 
Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY
Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study

To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.

Hypothesis: Coronary CT angiography (CCTA) employing a novel intracycle motion compensation algorithm (SnapShot Freeze [SSF]) will be superior to CCTA without an intracycle motion compensation algorithm ("conventional" CCTA) for diagnostic accuracy and image quality.

Scientific Basis: Preliminary study (Leipsic, Min, Journal of Cardiovascular Computed Tomography [in press]) of coronary CT angiograms in individuals undergoing pre-procedural assessment for transcatheter aortic valve replacement (n=36) demonstrate improved image quality of CCTA using SSF compared to CCTA not using SSF. Importantly, individuals in this study did not receive heart rate slowing agents (e.g., beta blockers), and diagnostic image quality was substantially improved. While not statistically powered on a per-patient basis, per-segment diagnostic accuracy of CCTA using SSF was superior to conventional CCTA. These results are complementary to those derived from internal testing at GE Healthcare wherein phantom work has demonstrated improved diagnostic performance using SSF compared to conventional image acquisitions.

Long-term Goal/Purpose: To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy. If the aims of this study are achieved, the use of SSF for effective temporal resolution improvement may obviate (or reduce) the need for CT hardware for improved temporal resolution.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
30 Days
Not Provided
Probability Sample

Consenting adult patients ≥18 years of age, Suspected but without known prior history of CAD, Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)

  • Coronary Artery Disease
  • Coronary Arteriosclerosis
Not Provided
CCTA Patient
  1. Consenting adult patients ≥18 years of age;
  2. Suspected but without known prior history of CAD
  3. Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
  4. Glomerular filtration rate >60 ml/min
  5. CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
218
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Consenting adult patients ≥18 years of age;
  2. Suspected but without known prior history of CAD
  3. Not actively taking heart rate lowering agents at least 48 hours prior to study (e.g., AV nodal blockers such as beta blockers, calcium channel blockers or digoxin)
  4. Glomerular filtration rate >60 ml/min
  5. CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)

Exclusion Criteria:

  1. Incomplete ICA or CCTA;
  2. Known CAD (prior myocardial infarction, PCI, CABG)
  3. Atrial Fibrillation
  4. Abnormal Renal Function (GFR <60 ml/min)
  5. Unwilling or unable to give consent
  6. Non-cardiac illness with life expectancy <1 year
  7. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
  8. Pregnant women
  9. Allergy to iodinated contrast agent
  10. Contraindications to nitroglycerin
  11. Systolic blood pressure ≤90 mm Hg
  12. Contraindications to β blockers or nitroglycerin
Both
18 Years and older
No
Contact: Dan Gebow, PhD 4152441481 dgebow@mddx.com
Italy,   Argentina,   India,   United States,   Canada
 
NCT01856504
VICTORY
No
MDDX LLC
MDDX LLC
GE Healthcare
Not Provided
MDDX LLC
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP