Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY

Completed

• Conditions: Coronary Arteriosclerosis; Coronary Artery Disease

• Registration Number: NCT01856504
• Lead Sponsor: MDDX LLC

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-17
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	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.
Diagnostic Interpretability	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.
Image quality	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.

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Midwest Cardiology Associates; 🇺🇸 Independence, Missouri, United States

Diagnostico Maipu; 🇦🇷 San Isidro, Argentina

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

FACTS; 🇮🇳 Hyderabad, India

MDDX; 🇺🇸 San Francisco, California, United States

Centro Cardiologico Monzino; 🇮🇹 Monzino, Italy

Walter Reed Medical Center; 🇺🇸 Bethesda, Maryland, United States