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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

General Publications

• Gutierrez LF, Silva Rd, Ozturk C, Sonmez M, Stine AM, Raval AN, Raman VK, Sachdev V, Aviles RJ, Waclawiw MA, McVeigh ER, Lederman RJ. Technology preview: X-ray fused with magnetic resonance during invasive cardiovascular procedures. Catheter Cardiovasc Interv. 2007 Nov 15;70(6):773-82. doi: 10.1002/ccd.21352.
• Phan A, Dalle S, Thomas L. [Acquired pigmented lesion of the finger pulp]. Ann Dermatol Venereol. 2009 May;136(5):477-8. doi: 10.1016/j.annder.2008.09.020. Epub 2009 Mar 10. No abstract available. French.
• Tenaza RR. Songs, choruses and countersinging of Kloss' gibbons (Hylobates klossii) in Siberut Island, Indonesia. Z Tierpsychol. 1976 Jan;40(1):37-52. doi: 10.1111/j.1439-0310.1976.tb00924.x.

Study record dates

Study Major Dates

• Study Start: August 6, 2009
• Primary Completion: December 7, 2022
• Study Completion: May 27, 2010

Study Registration Dates

• First Submitted: August 24, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: May 27, 2010

More Information

Terms related to this study

• Keywords: Aortic Valve Stenosis; Cardiac CT; Heart Valve; Iodinated Radiocontrast; Ionizing Radiation; Percutaneous Aortic Valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 090211; 09-H-0211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No