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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01856504
Other study ID # VICTORY
Secondary ID
Status Completed
Phase N/A
First received May 15, 2013
Last updated March 31, 2015
Start date May 2013
Est. completion date March 2015

Study information

Verified date March 2015
Source MDDX LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 218
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 ß blockers or nitroglycerin

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Argentina Diagnostico Maipu San Isidro
Canada University of British Columbia Vancouver British Columbia
India FACTS Hyderabad
Italy Centro Cardiologico Monzino Monzino
United States Walter Reed Medical Center Bethesda Maryland
United States Midwest Cardiology Associates Independence Missouri
United States MDDX San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
MDDX LLC GE Healthcare

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  India,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic Accuracy 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 No
Primary Diagnostic Interpretability 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 No
Primary Image quality 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 No
Secondary Upper threshold of heart rate To determine the upper threshold of heart rate below which CCTA with SSF is most effective. 1 day No
Secondary incremental & additive value To determine the incremental & additive value of SSF to conventional CCTA for diagnostic accuracy / diagnostic interpretability / image quality. 1 day Yes
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