- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01638156
Cardiac MRI for Severe Aortic Stenosis
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Cynthia Olson
- Phone Number: 215 574-3234
- Email: colson@acr.org
Study Contact Backup
- Name: Rosa M Medina
- Phone Number: 215 940-8891
- Email: rmedina@acr.org
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Philadelphia VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac MRI before and after to detect changes in response to aortic valve replacement (AVR) for sever aortic stenosis.
Time Frame: 1-2 years
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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.
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1-2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 1-2 years
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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.
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1-2 years
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Myocardial T1rho mapping
Time Frame: 1-2 years
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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.
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1-2 years
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Changes in myocardial T1rho after AVR
Time Frame: 1-2 years
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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.
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1-2 years
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Stiffness and reflection correlates with physical fitness after AVR
Time Frame: 1-2 years
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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.
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1-2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Scott Akers, MD, PhD, Philadelphia Veterans Administration Medical Center
- Study Chair: Julio A. Chirinos, MD, Philadelphia Veterans Administration Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACRIN PA 4008
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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