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Aortic StenosisNCT01638156

Cardiac MRI for Severe Aortic Stenosis

An observational study of Aortic Stenosis, run by American College of Radiology at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the importance of arterial stiffness and wave reflections as determinants of persistent left ventricular (LV) hypertrophy and fibrosis (assessed using cardiac magnetic resonance imaging [MRI]) after correction of severe stenosis of the aortic valve. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Stenosis
How many people
39 participants
Where
2 sitesUnited States
Study dates
Jun 2013to 31 Dec 2015
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

Study population: Patients who are 18 years of age or older with no contraindications to gadolinium contrast-enhanced MRI of the heart who are able to have a cardiac MRI in the 21 days before the AVR operation, have been diagnosed with severe symptomatic aortic stenosis (estimated aortic valve area <1 cm2),1,2 and are scheduled for AVR between 0 and 28 days after enrollment. Potential participants will have undergone a clinically indicated pre-operative evaluation showing the absence of hemodynamically-significant CAD that would require revascularization during the AVR operation.

Who may be able to join

  • 18 years of age or older
  • Severe symptomatic aortic stenosis (estimated aortic valve area <1 cm2) 1,2 as documented on a transthoracic echocardiogram (ECG) performed within 4 months prior to enrollment
  • Planned for AVR within 8 weeks after enrollment
  • Able to have a cardiac MRI within 3 weeks prior to the AVR surgery
  • A preoperative coronary angiography demonstrating the absence of hemodynamically-significant CAD in need of revascularization during AVR surgery
  • Able to tolerate cardiac MRI with gadolinium contrast as required by protocol, to be performed at an ACRIN-qualified facility using an ACRIN-qualified MR scanner
  • Willing and able to provide a written informed consent

Who cannot join

  • Not suitable to undergo cardiac MRI or use the contrast agent gadolinium because of:
  • Claustrophobia
  • Presence of metallic objects or implanted medical devices in body (i.e., implanted cardiac pacemaker or defibrillator, central nervous system aneurysm clips, implanted neural stimulators, cochlear implant, ocular foreign body [e.g., metal shavings], other implanted medical devices [e.g., drug infusion port], insulin pump, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
  • Weight greater than that allowable by the MRI table
  • Known LV ejection fraction <50%
  • Previous aortic valve surgery
Show all 23Show fewer
  • Planned additional valve repair/replacement
  • Infective endocarditis
  • Moderate or severe aortic valve regurgitation
  • Rhythm other than sinus rhythm (i.e., atrial fibrillation) that results in an irregular heartbeat, compromising the quality of MRI and tonometry data acquisition, as documented on an ECG performed within 8 weeks prior to enrollment
  • Presence of hemodynamically-significant CAD that would require revascularization during the AVR surgery
  • Myocardial infarction or unstable angina in the previous month
  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 of body surface area documented within 4 weeks prior to enrollment
  • NOTE: This threshold has been deemed appropriate for this study, rather than <30 mL/min/1.73m2, since eGFR is likely to decrease for participants between the baseline and 6-month examinations. The protocol calls for gadolinium administration in the 6-month evaluation, and gadolinium administration is contraindicated in the presence of an eGFR <30 mL/min/1.73m2. Therefore, initially excluding patients who have an eGFR < 60 mL/min/1.73m2 will minimize the presence of an eGFR <30 mL/min/1.73m2 at the time of the 6-month evaluation.
  • An eGFR < 30 mL/min/1.73m2 of body surface area or acute kidney injury will be a contraindication to gadolinium contrast administration, and participants with insufficient kidney function immediately before the 6-month cardiac MRI will undergo an MRI without contrast-enhancement and will continue on-study.
  • Presence of a bicuspid aortic valve, which is associated with an intrinsic aortopathy that may affect arterial load in its own right;
  • Resting heart rate >120 beats per minute, systolic blood pressure >180 mm Hg, or diastolic blood pressure > 100 mm Hg
  • Pregnancy or intent to become pregnant
  • Conditions that would make the study measurements less accurate or unreliable (i.e., frequent premature beats that may affecting cardiac gating, anatomic neck characteristics impeding arterial tonometry, inability to perform an adequate breath hold for cardiac MRI acquisitions) or the reliable post-operative follow-up of patients (for at least 6 months post-AVR) unlikely
  • Known peripheral vascular disease, which may limit the ability to exercise independently of cardiac status due to claudication
  • Unwillingness of the patient to undergo a cardiac MRI
  • Unwillingness of the patient to sign the consent form
  • Any condition limiting life expectancy to <1 year

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Philadelphia VA Medical Center

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Arterial Stiffness and Wave Reflections as Determinants of Regression of Left Ventricular Hypertrophy and Fibrosis Assessed With Cardiac MRI After Aortic Valve Replacement for Severe Aortic Stenosis

This study will evaluate the importance of arterial stiffness and wave reflections as determinants of persistent left ventricular (LV) hypertrophy and fibrosis (assessed using cardiac magnetic resonance imaging [MRI]) after correction of severe stenosis of the aortic valve. The hypothesis will test whether stiff arteries and increased wave reflections impede pumping of blood by the LV after aortic valve replacement (AVR)and precent adequate regression (improvement) of hypertrophy and fibrosis of the myocardium despite correction of aortic valve stenosis.

Read the detailed description

A total of 80 participants will be enrolled into the study from site with the protocol-required technology. The Pennsylvania Department of Health funding for this trial is limited to sites in Pennsylvania. Participants will undergo pre- and post-operative cardiac MRI, blood draws, a 6-minute walk test, arterial tonometry, medical history assessment, and quality-of-life questionnaires to characterize the pathophysiologic factors causing variability in regression after AVR. Researchers will evaluate the role of specific hemodynamic abnormalities as determinants of post-AVR LV remodeling (LV hypertrophy and LV myocardial fibrosis) as seen on contrast-enhanced cardiac MRI. The trial also will evaluate a non-contrast-enhanced MRI approach (T1rho) potentially effective in assessing LV myocardial fibrosis.

Conditions
Aortic Stenosis
Keywords
Aortic stenosis
Medical subject headings
Aortic Valve Stenosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac MRI before and after to detect changes in response to aortic valve replacement (AVR) for sever aortic stenosis.

    To test the hypothesis that increased stiffness of the aortic wall and arterial wave reflections correlate with an adequate regression (improvement) of LV hypertrophy and LV myocardial fibrosis measured with cardiac MRI after AVR for severe aortic stenosis.

    Measured: 1-2 years

Secondary outcomes (4)

  1. Evaluate role of specific hemodynamic abnormalities that depend on systemic arteries, as determinants of post-AVR improvement in left ventricular (LV) remodeling (LV hypertrophy and LV myocardial fibrosis)

    To test the hypothesis that increased stiffness of the aortic wall and increased arterial wave reflections are important determinants of LV hypertrophy and LV myocardial fibrosis in participants with severe aortic stenosis.

    Measured: 1-2 years

  2. Myocardial T1rho mapping

    To test the hypothesis that myocardial T1rho mapping, a novel myocardial tissue characterization MRI technique, correlates with LV myocardial fibrosis assessed with post-gadolinium myocardial T1 measurements in participants with severe aortic stenosis.

    Measured: 1-2 years

  3. Changes in myocardial T1rho after AVR

    To test the hypothesis that changes in myocardial T1rho after AVR in participants with severe aortic stenosis correlates with changes in LV myocardial fibrosis assessed with post-gadolinium myocardial T1 measurements.

    Measured: 1-2 years

  4. Stiffness and reflection correlates with physical fitness after AVR

    To test the hypothesis that increased stiffness of the aortic wall and arterial wave reflections correlate with physical fitness (assessed via a 6-minute walk test) after AVR for severe aortic stenosis.

    Measured: 1-2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2012 (estimated)
  2. Study startJun 2013
  3. Primary completion31 Dec 2015
  4. Study completion31 Dec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01638156
Sponsor's protocol ID
ACRIN PA 4008
Status last verified
Jul 2023
First submitted
9 Jul 2012
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Stenosis, run by American College of Radiology at 2 sites 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 7 inclusion and 23 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 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does the primary outcome measure?

Cardiac MRI before and after to detect changes in response to aortic valve replacement (AVR) for sever aortic stenosis. (time frame: 1-2 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 NCT01638156.

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 1 Aug 2023.

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