Clinical trial NCT01856504: Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY
Official title: Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Arteriosclerosis
Keywords: Heart Disease
Coronary Artery Disease
Coronary Arteriosclerosis
Lead sponsor: MDDX LLC
Sponsor class: INDUSTRY
Collaborators: name: GE Healthcare
First posted: 2013-05-17
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

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 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

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: 30 days
measure: Diagnostic Interpretability
timeFrame: 30 days
measure: Image quality
timeFrame: 30 day
Secondary outcomes:
measure: Upper threshold of heart rate
timeFrame: 1 day
measure: incremental & additive value
timeFrame: 1 day
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: MDDX
state: California
city: Bethesda
country: United States
facility: Walter Reed Medical Center
state: Maryland
city: Independence
country: United States
facility: Midwest Cardiology Associates
state: Missouri
city: San Isidro
country: Argentina
facility: Diagnostico Maipu
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Hyderabad
country: India
facility: FACTS
city: Monzino
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
References: