X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2009 |
| End Date: | May 2010 |
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.
- 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.
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-necessary fluoroscopy from cardiac catheterization to learn whether
they can be combined to enhance future minimally invasive valve treatments.
stenosis being considered for surgical or catheter treatment. These data will be analyzed
along with medically-necessary fluoroscopy from cardiac catheterization to learn whether
they can be combined to enhance future minimally invasive valve treatments.
- 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:
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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