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
  Purpose

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


Condition
Coronary Artery Disease
Coronary Arteriosclerosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by MDDX LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 218
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856504

Contacts
Contact: Dan Gebow, PhD 4152441481 dgebow@mddx.com

Locations
United States, California
MDDX Not yet recruiting
San Francisco, California, United States, 94104
Contact: Dan Gebow, PhD    415-244-1481    dgebow@mddx.com   
Principal Investigator: Dan Gebow, PhD         
United States, Maryland
Walter Reed Medical Center Not yet recruiting
Bethesda, Maryland, United States
Contact: Todd Villines, MD         
Principal Investigator: Todd Villines, MD         
United States, Missouri
Midwest Cardiology Associates Recruiting
Independence, Missouri, United States
Contact: Stephen Bloom, MD         
Argentina
Diagnostico Maipu Recruiting
San Isidro, Argentina
Contact: Patricia Carrascosa, MD         
Principal Investigator: Patricia Carrascosa, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 1Z4
Contact: Elizabeth Grieve    604 682-2344 ext 62529    egrieve@providencehealth.bc.ca   
Contact: Trisha Duval    917 837 7911    tduval@createresearchllc.com   
Sub-Investigator: Jonathan Leipsic, MD         
Sub-Investigator: Brett Heilbron, MD         
India
FACTS Recruiting
Hyderabad, India
Contact: Ravi Bathina, MD         
Principal Investigator: Daniel Friedman, MD         
Italy
Centro Cardiologico Monzino Recruiting
Monzino, Italy
Contact: Daniele Andreini, MD         
Principal Investigator: Daniele Andreini         
Sponsors and Collaborators
MDDX LLC
GE Healthcare
  More Information

No publications provided

Responsible Party: MDDX LLC
ClinicalTrials.gov Identifier: NCT01856504     History of Changes
Other Study ID Numbers: VICTORY
Study First Received: May 15, 2013
Last Updated: October 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by MDDX LLC:
Heart Disease
Coronary Artery Disease
Coronary Arteriosclerosis

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on August 19, 2014