X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development
Completed
Conditions studied: Aortic Valve Stenosis
In brief
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 stenosis (narrowing of the aorta because of calcium deposits). * Comparing the data received from CT scans with the data received from heart catheterization (which assesses the heart's condition and function) can be used to improve treatment in patients with certain heart conditions. Researchers are interested in looking at the effectiveness of both procedures in assessing possible surgical treatments for patients with calcific aortic stenosis. Objectives: \- To analyze cardiac CT scans in conjunction with existing heart scan results to improve treatments for future minimally invasive aortic valve replacement. Eligibility: \- Patients 18 years of age and older who have been diagnosed with aortic valve stenosis that may be treated surgically, and who will undergo or have recently undergone heart catheterization. Design: * Participants will have a CT scan within 90 days of the medically necessary heart catheterization, but before any other surgical or catheter treatment. * During the CT scan, patients will be asked to hold their breath intermittently for about 5 to 20 seconds. Patients will be inside the scanner for less than 30 minutes. * Patients will be asked to return in 3 to 7 days for a blood test to check kidney function. * Researchers will analyze the results of the CT scan in conjunction with the previous results from the catheterization to determine possible improved treatment options.
Key facts
- Study ID
- NCT00965679
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 1
- Starts
- 2009-08-06
- Expected to finish
- 2010-05-27
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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