Cardiac MRI for Severe Aortic Stenosis

NCT01638156 | Completed DMC

• 1 other identifier: ACRIN PA 4008
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Aortic Stenosis

Keywords

Aortic stenosis

Outcome Measures

Primary Outcomes (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.

  1-2 years

Secondary Outcomes (4)

• 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)

  1-2 years

• Myocardial T1rho mapping

  1-2 years

• Changes in myocardial T1rho after AVR

  1-2 years

• Stiffness and reflection correlates with physical fitness after AVR

  1-2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American College of Radiology: lead
• Pennsylvania Department of Health: collaborator

Study Sites (2)

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collecting three tubes of blood: 10-mL of blood for plasma sampling, 10-mL of serum, and a microtube or other adequate sample for hematocrit measurements. Hematocrit measurements within 24 hours prior to the cardiac MRI scan. Serum and plasma samples will be stored at -80°C in 0.5 mL vials.

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Scott Akers, MD, PhD

  Philadelphia Veterans Administration Medical Center

  STUDY CHAIR

• Julio A. Chirinos, MD

  Philadelphia Veterans Administration Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 11, 2012
• Study Start: June 1, 2013
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (2)