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

September 12, 2019 updated by: National Heart, Lung, and Blood Institute (NHLBI)

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.

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.

Study Overview

Status

Withdrawn

Conditions

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators

Medstar Washington Hospital Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 27, 2013

Primary Completion (Anticipated)

December 31, 2016

Study Completion (Anticipated)

December 31, 2016

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

April 8, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130168
  • 13-H-0168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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