Coronary Artery Disease Clinical Trial
— VICTORYOfficial title:
Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY: A Prospective Multicenter Study
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] |
To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
MDDX LLC | GE Healthcare |
United States, Argentina, Canada, India, Italy,
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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