Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY

Completed

Conditions studied: Coronary Artery Disease, Coronary Arteriosclerosis

In brief

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

Key facts

Study ID

NCT01856504

Run by

MDDX LLC

People needed

218

Starts

2013-05-01

Expected to finish

2015-03-01

Last updated by the study team

2015-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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