Status:
COMPLETED
X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
Background: * Computed tomography (CT) creates three-dimensional images based on X-ray imaging. CT is useful for determining treatment approaches for certain diseases, such as calcific aortic stenosi...
Detailed Description
We will collect cardiac computed tomography (CT) data from patients with aortic valve stenosis being considered for surgical or catheter treatment. These data will be analyzed along with medically-nec...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- SELECTION CRITERIA: PATHWAY FOR RESEARCH CT:
- Adult patients age 18 years or older
- Having calcific aortic stenosis being considered for surgical or catheter-based treatment, determined on physical examination or noninvasive imaging such as echocardiography
- Undergoing diagnostic cardiac catheterization within 1 year
- Able to provide informed consent
- ALTERNATIVE SELECTION CRITERIA: PATHWAY FOR ANALYSIS OF MEDICAL DATA:
- Adult patients age 18 years or older
- Having calcific aortic stenosis being considered for surgical or catheter-based treatment, determined on physical examination or noninvasive imaging such as echocardiography
- Undergoing diagnostic cardiac catheterization within 1 year
- Having undergone cardiac CT for medical indications meeting the technical requirements of this protocol
- Able to provide informed consent
- EXCLUSION CRITERIA:
- SELECTION CRITERIA: PATHWAY FOR RESEARCH CT:
- Pregnant or lactating women
- Decompensated heart failure (unable to lie flat during CT)
- EXCLUSION CRITERIA FOR BETA ADRENERGIC BLOCKERS:
- Advanced atrioventricular block (Mobitz Type II second degree or third degree atrioventricular heart block)
- Asthma or chronic obstructive pulmonary disease (emphysema) currently treated with beta adrenergic agonists
- EXCLUSION CRITERIA FOR IODINATED RADIOCONTRAST:
- Severe kidney disease (MDRD estimated Glomerular Filtration Rate
- \< 30mL/min/l.73m(2)).
- Request of referring physician or surgeon not to administer iodinated radiocontrast
- ALTERNATIVE SELECTION CRITERIA: PATHWAY FOR ANALYSIS OF MEDICAL DATA:
- None
Exclusion
Key Trial Info
Start Date :
August 6 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 27 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00965679
Start Date
August 6 2009
End Date
May 27 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892