Aortic Valve StenosisNCT01905852
Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis
An observational study of Aortic Valve Stenosis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
Background: Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of ways, including replacing a heart valve. Objectives: Researchers want to study fibrosis in the heart. 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2013to 31 Dec 2016
- 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
- Subjects must meet all the following inclusion criteria prior to enrollment into the trial:
- Severe aortic stenosis defined as aortic valve area of less than 1 cm(2) or index area of 0.6 cm(2)/m(2) by echocardiography.
- Symptomatic patients with aortic stenosis referred for medically indicated AVR
- LV EF less than or equal to 0.50
- Signed informed consent to participate in the study.
- Specific criteria for MR perfusion sub-study:
- Absence of any significant coronary lesions or presence of coronary disease for conservative (medical) therapy<TAB>.
Who cannot join
- Inability to sign written informed consent.
- Subjects with contraindication to MRI scanning, including the following devices or conditions:
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
- Neural stimulator (e.g. TENS-Unit)
- Any type of ear implant
Show all 25Show fewer
- Ocular foreign body (e.g. metal shavings)
- Any implanted device (e.g. insulin pump, drug infusion device)
- Metal shrapnel or bullet.
- Atrial fibrillation
- Subjects with a known hypersensitivity, allergy or contraindication to iodine or gadolinium
- Impaired renal excretory function, calculated as Glomerular Filtration Rate (GFR) <30mL/min/1.73m(2).
- Contraindications for intravenous adenosine infusion:
- Known hypersensitivity to adenosine
- Known or suspected significant bronchoconstrictive or bronchospastic disease
- 2nd or 3rd degree atrioventricular (AV) block unless with permanent pacemaker
- Sinus bradycardia (heart rate < 45 bpm) unless with permanent pacemaker
- Systemic arterial hypotension (< 90 mmHg)
- Presence of any coexisting severe valvular disorder.
- Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
- Need for emergency surgery for any reason.
- Any case in which the practicing physician asserts that enrollment in the protocol will adversely affect the patient treatment course.
- Specific exclusion criteria for MR perfusion sub-study:
- No detectable reversible ischemia on pre-treatment/procedure cardiac MRI.
- Subject underwent transcatheter AVR as part of one of the transcatheter heart valve trials (i.e. PARTNER trial or the pivotal CoreValve trial).
About this study
Official title: Utilization of Cardiac Magnetic Resonance Imaging to Predict Clinical Outcomes of Patients With Severe Aortic Stenosis
Background:
- Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of ways, including replacing a heart valve.
Read more
Objectives:
Researchers want to study fibrosis in the heart. A sub-study will test whether heart function and blood supply improve after a valve replacement.
Eligibility:
- Adults at least 18 years old with aortic stenosis.
Design:
- Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their heart. This uses magnets, radio waves, and computers to produce detailed pictures of the heart.
- After this visit, participants will have their aortic valve procedure at the the Washington Hospital Center. A hospital team will contact participants for 1 year by phone or email. This follow-up will consist of 15 minutes of questions about the participant s health status.
- Some participants will join a sub-study.
- They will be given an additional medication to evaluate the blood supply of the heart.
- They will visit a clinic for 1 day for an MRI of their heart, as part of the main study, prior to the aortic valve replacement.
- After they have their valve replaced at the hospital, they will return to the clinic for another MRI.
- They will have the same follow-up as in the main study.
Read the detailed description
Aortic valve stenosis is a disease that causes narrowing of a major heart valve, and that reduces heart function and causes death. The purpose of this protocol is to use magnetic resonance imaging of the heart to identify which patients would benefit from replacement of the diseased valve.
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement, Ejection Fraction, Fractional Flow Reserve, Myocardial Fibrosis
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study start27 Jun 2013
- Primary completion31 Dec 2016 (estimated)
- Study completion31 Dec 2016 (estimated)
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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Medstar Health Research Institute
- Responsible party
- Sponsor
- Investigators
- Andrew E Arai, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905852
- Sponsor's protocol ID
- 130168
- Other IDs
- 13-H-0168
- Status last verified
- 8 Apr 2014
- First submitted
- 18 Jul 2013
- Last updated
- 13 Sep 2019
- Results posted
- No
Publications
Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.
PubMed 22443479Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26.
PubMed 22443478Fraccaro C, Al-Lamee R, Tarantini G, Maisano F, Napodano M, Montorfano M, Frigo AC, Iliceto S, Gerosa G, Isabella G, Colombo A. Transcatheter aortic valve implantation in patients with severe left ventricular dysfunction: immediate and mid-term results, a multicenter study. Circ Cardiovasc Interv. 2012 Apr;5(2):253-60. doi: 10.1161/CIRCINTERVENTIONS.111.964213. Epub 2012 Apr 10.
PubMed 22496081
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Cardiac Magnetic Resonance Imaging to Predict Clinical Outcomes of Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT01905852
- Acronym / sponsor ID
- 130168
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement, Ejection Fraction, Fractional Flow Reserve, Myocardial Fibrosis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Collaborators
- Medstar Health Research Institute
- Study start
- 27 Jun 2013
- Primary completion
- 31 Dec 2016 (estimated)
- Study completion
- 31 Dec 2016 (estimated)
- First posted
- 23 Jul 2013 (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:
- Aortic valve stenosis is a disease that makes a major heart valve get smaller. This reduces heart function and causes death. Severe aortic stenosis (AS) can be treated in a couple of ways, including replacing a heart valve.
Objectives:
Researchers want to study fibrosis in the heart. A sub-study will test whether heart function and blood supply improve after a valve replacement.
Eligibility:
- Adults at least 18 years old with aortic stenosis.
Design:
- Participants will visit a clinic for 1 day for magnetic resonance imaging (MRI) of their heart. This uses magnets, radio waves, and computers to produce detailed pictures of the heart.
- After this visit, participants will have their aortic valve procedure at the the Washington Hospital Center. A hospital team will contact participants for 1 year by phone or email. This follow-up will consist of 15 minutes of questions about the participant s health status.
- Some participants will join a sub-study.
- They will be given an additional medication to evaluate the blood supply of the heart.
- They will visit a clinic for 1 day for an MRI of their heart, as part of the main study, prior to the aortic valve replacement.
- After they have their valve replaced at the hospital, they will return to the clinic for another MRI.
- They will have the same follow-up as in the main study.
Detailed description
Aortic valve stenosis is a disease that causes narrowing of a major heart valve, and that reduces heart function and causes death. The purpose of this protocol is to use magnetic resonance imaging of the heart to identify which patients would benefit from replacement of the diseased valve.
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 (7 listed)
- Subjects must meet all the following inclusion criteria prior to enrollment into the trial:
- Severe aortic stenosis defined as aortic valve area of less than 1 cm(2) or index area of 0.6 cm(2)/m(2) by echocardiography.
- Symptomatic patients with aortic stenosis referred for medically indicated AVR
- LV EF less than or equal to 0.50
- Signed informed consent to participate in the study.
Key exclusion criteria (25 listed)
- Inability to sign written informed consent.
- Subjects with contraindication to MRI scanning, including the following devices or conditions:
- Subjects with a known hypersensitivity, allergy or contraindication to iodine or gadolinium
- Impaired renal excretory function, calculated as Glomerular Filtration Rate (GFR) <30mL/min/1.73m(2).
- Contraindications for intravenous adenosine infusion:
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
To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR.
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Background: PubMed 22443479Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.
- Background: PubMed 22443478Makkar RR, Fontana GP, Jilaihawi H, Kapadia S, Pichard AD, Douglas PS, Thourani VH, Babaliaros VC, Webb JG, Herrmann HC, Bavaria JE, Kodali S, Brown DL, Bowers B, Dewey TM, Svensson LG, Tuzcu M, Moses JW, Williams MR, Siegel RJ, Akin JJ, Anderson WN, Pocock S, Smith CR, Leon MB; PARTNER Trial Investigators. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012 May 3;366(18):1696-704. doi: 10.1056/NEJMoa1202277. Epub 2012 Mar 26.
- Background: PubMed 22496081Fraccaro C, Al-Lamee R, Tarantini G, Maisano F, Napodano M, Montorfano M, Frigo AC, Iliceto S, Gerosa G, Isabella G, Colombo A. Transcatheter aortic valve implantation in patients with severe left ventricular dysfunction: immediate and mid-term results, a multicenter study. Circ Cardiovasc Interv. 2012 Apr;5(2):253-60. doi: 10.1161/CIRCINTERVENTIONS.111.964213. Epub 2012 Apr 10.
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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.
Andrew E Arai, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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).
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 7 inclusion and 25 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: withdrawn, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
To assess the ability of cardiac MRI measurement of extracellular volume fraction (related to myocardial fibrosis) to predict short and long term LV function of subjects with severe aortic stenosis undergoing transcatheter AVR. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905852, 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 13 Sep 2019.