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

March 31, 2015 updated by: MDDX LLC

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • San Isidro, Argentina
        • Diagnostico Maipu
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z4
        • University of British Columbia
  • India
      • Hyderabad, India
        • FACTS
  • Italy
      • Monzino, Italy
        • Centro Cardiologico Monzino
  • United States
    • California
      • San Francisco, California, United States, 94104
        • MDDX
    • Maryland
      • Bethesda, Maryland, United States
        • Walter Reed Medical Center
    • Missouri
      • Independence, Missouri, United States
        • Midwest Cardiology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy
Time Frame: 30 days
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.
30 days
Diagnostic Interpretability
Time Frame: 30 days
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.
30 days
Image quality
Time Frame: 30 day
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.
30 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper threshold of heart rate
Time Frame: 1 day
To determine the upper threshold of heart rate below which CCTA with SSF is most effective.
1 day
incremental & additive value
Time Frame: 1 day
To determine the incremental & additive value of SSF to conventional CCTA for diagnostic accuracy / diagnostic interpretability / image quality.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MDDX LLC

Collaborators

GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (Estimate)

May 17, 2013

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICTORY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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