X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00965679
First received: August 24, 2009
Last updated: May 28, 2010
Last verified: May 2010
  Purpose

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.

Condition
Aortic Valve Stenosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 1
Study Start Date: August 2009
Estimated Study Completion Date: May 2010
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-necessary fluoroscopy from cardiac catheterization to learn whether they can be combined to enhance future minimally invasive valve treatments.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965679

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00965679     History of Changes
Other Study ID Numbers: 090211, 09-H-0211
Study First Received: August 24, 2009
Last Updated: May 28, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cardiac CT
Iodinated Radiocontrast
Ionizing Radiation
Aortic Valve Stenosis
Percutaneous Aortic Valve Replacement
Heart Valve

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 22, 2014