Clinical trial NCT03183011: Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy
Official title: Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: cardiac resynchronization therapy
implantable cardioverter defibrillator
heart failure
magnetic resonance imaging
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is evaluating how MRI after CRT can provide key insights regarding LV function, structure, and mechanics resulting from CRT in patients with or without LV scar and inform optimal pacing strategies. The expected accurate and reproducible response assessment with cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and the insights from the post-CRT MRI promise to improve implementation of CRT.

Detailed description: We are performing a study of 40 patients with current accepted indications for CRT and no MRI contraindications. These patients will have a pre-CRT MRI and another post-CRT MRI 6 months after the CRT procedure. Echocardiography, cardiopulmonary exercise testing, symptom assessment, and laboratory testing are also performed before and after CRT. Modifications to the post-CRT MRI protocol include the use of gradient echo cine imaging rather than steady state free precession imaging, application of wideband imaging to the LGE acquisitions, and strain imaging with cine Displacement Encoding with Stimulated Echoes (DENSE) tailored for device patients.

Eligibility criteria: Inclusion Criteria:

* Chronic systolic HF
* LVEF 35% or less
* Guideline-based class I or IIa indication for CRT
* 25 and 85 years old
* Predominantly in sinus rhythm
* GFR ≥ 40 ml/min/1.73m2\* \*Contrast will not be given for the 6-month follow-up scan if the GFR falls to \< 40 ml/min/1.73m2.

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
* Preexisting pacemaker or defibrillator prior to enrollment
* Cerebral aneurysm clips; 6) cochlear implants
* Other metallic implants (prior to enrollment) known to be contraindications to MRI
* Severe claustrophobia
* Acute kidney injury
* Acute renal failure or chronic kidney disease with GFR \< 40 cc/min
* Liver transplant
* Gadolinium allergy

Primary outcomes:
measure: CRT Response
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Kenneth C Bilchick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Auger DA, Bilchick KC, Gonzalez JA, Cui SX, Holmes JW, Kramer CM, Salerno M, Epstein FH. Imaging left-ventricular mechanical activation in heart failure patients using cine DENSE MRI: Validation and implications for cardiac resynchronization therapy. J Magn Reson Imaging. 2017 Sep;46(3):887-896. doi: 10.1002/jmri.25613. Epub 2017 Jan 9.
citation: Ramachandran R, Chen X, Kramer CM, Epstein FH, Bilchick KC. Singular Value Decomposition Applied to Cardiac Strain from MR Imaging for Selection of Optimal Cardiac Resynchronization Therapy Candidates. Radiology. 2015 May;275(2):413-20. doi: 10.1148/radiol.14141578. Epub 2015 Jan 9.