Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01905852
Recruitment Status : Withdrawn
First Posted : July 23, 2013
Last Update Posted : February 14, 2018
Medstar Washington Hospital Center
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:


- 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.


Researchers want to study fibrosis in the heart. A sub-study will test whether heart function and blood supply improve after a valve replacement.


- Adults at least 18 years old with aortic stenosis.


  • 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.

Condition or disease
Aortic Valve Stenosis

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 Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Official Title: Utilization of Cardiac Magnetic Resonance Imaging to Predict Clinical Outcomes of Patients With Severe Aortic Stenosis
Study Start Date : June 27, 2013
Estimated Primary Completion Date : December 31, 2016
Estimated Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Subjects must meet all the following inclusion criteria prior to enrollment into the trial:

  1. 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.
  2. Symptomatic patients with aortic stenosis referred for medically indicated AVR
  3. LV EF less than or equal to 0.50
  4. Signed informed consent to participate in the study.

    Specific criteria for MR perfusion sub-study:

  5. Absence of any significant coronary lesions or presence of coronary disease for conservative (medical) therapy<TAB>.


  1. Inability to sign written informed consent.
  2. 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
    • Ocular foreign body (e.g. metal shavings)
    • Any implanted device (e.g. insulin pump, drug infusion device)
    • Metal shrapnel or bullet.
    • Atrial fibrillation
  3. Subjects with a known hypersensitivity, allergy or contraindication to iodine or gadolinium
  4. Impaired renal excretory function, calculated as Glomerular Filtration Rate (GFR) <30mL/min/1.73m(2).
  5. 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)
  6. Presence of any coexisting severe valvular disorder.
  7. Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
  8. Need for emergency surgery for any reason.
  9. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01905852

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Medstar Washington Hospital Center
Principal Investigator: Andrew E Arai, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT01905852     History of Changes
Other Study ID Numbers: 130168
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: April 8, 2014

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Transcatheter Aortic Valve Replacement
Ejection Fraction
Fractional Flow Reserve
Myocardial Fibrosis

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction