Status:
COMPLETED
Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY
Lead Sponsor:
MDDX LLC
Collaborating Sponsors:
GE Healthcare
Conditions:
Coronary Artery Disease
Coronary Arteriosclerosis
Eligibility:
All Genders
18+ years
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 algor...
Eligibility Criteria
Inclusion
- 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)
- Glomerular filtration rate \>60 ml/min
- CCTA and ICA within 1 week of each other with no interscan event (e.g., myocardial infarction or coronary revascularization)
Exclusion
- Incomplete ICA or CCTA;
- Known CAD (prior myocardial infarction, PCI, CABG)
- Atrial Fibrillation
- Abnormal Renal Function (GFR \<60 ml/min)
- Unwilling or unable to give consent
- Non-cardiac illness with life expectancy \<1 year
- Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
- Pregnant women
- Allergy to iodinated contrast agent
- Contraindications to nitroglycerin
- Systolic blood pressure ≤90 mm Hg
- Contraindications to β blockers or nitroglycerin
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01856504
Start Date
May 1 2013
End Date
March 1 2015
Last Update
April 3 2015
Active Locations (7)
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1
MDDX
San Francisco, California, United States, 94104
2
Walter Reed Medical Center
Bethesda, Maryland, United States
3
Midwest Cardiology Associates
Independence, Missouri, United States
4
Diagnostico Maipu
San Isidro, Argentina