Aortic Valve StenosisNCT00965679
X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development
An observational study of Aortic Valve Stenosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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 stenosis (narrowing of the aorta because of calcium deposits). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2009to 27 May 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- SELECTION CRITERIA: PATHWAY FOR RESEARCH CT:
- Pregnant or lactating women
- Decompensated heart failure (unable to lie flat during CT)
- 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
- -Severe kidney disease (MDRD estimated Glomerular Filtration Rate
Show all 10Show fewer
- < 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Keywords
- Cardiac CT, Iodinated Radiocontrast, Ionizing Radiation, Aortic Valve Stenosis, Percutaneous Aortic Valve Replacement, Heart Valve
- Medical subject headings
- Aortic Valve Stenosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study start6 Aug 2009
- Study completion27 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965679
- Sponsor's protocol ID
- 090211
- Other IDs
- 09-H-0211
- Status last verified
- 27 May 2010
- First submitted
- 24 Aug 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
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.
PubMed 18022851Phan 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.
PubMed 19442811Tenaza 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.
PubMed 1274481
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development
- ClinicalTrials.gov ID
- NCT00965679
- Acronym / sponsor ID
- 090211
- Conditions
- Aortic Valve Stenosis
- Keywords
- Cardiac CT, Iodinated Radiocontrast, Ionizing Radiation, Aortic Valve Stenosis, Percutaneous Aortic Valve Replacement, Heart Valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 6 Aug 2009
- Study completion
- 27 May 2010
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Adult patients age 18 years or older
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Decompensated heart failure (unable to lie flat during CT)
- 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
- -Severe kidney disease (MDRD estimated Glomerular Filtration Rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 18022851Gutierrez 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.
- Background: PubMed 19442811Phan 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.
- Background: PubMed 1274481Tenaza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00965679, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.