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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Medstar Washington Hospital Center
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT01905852
First received: July 18, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.

Condition
Aortic Valve Stenosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Utilization of Cardiac Magnetic Resonance Imaging to Predict Clinical Outcomes of Patients With Severe Aortic Stenosis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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> .

EXCLUSION CRITERIA:

  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).

  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: NCT01905852

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

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01905852     History of Changes
Other Study ID Numbers: 130168, 13-H-0168
Study First Received: July 18, 2013
Last Updated: April 9, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Transcatheter Aortic Valve Replacement
Ejection Fraction
Fractional Flow Reserve
Myocardial Fibrosis

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

ClinicalTrials.gov processed this record on July 29, 2014