Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

NCT ID: NCT03183011

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2018-12-31

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.

Conditions

Heart Failure, Systolic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Post-CRT MRI

This study has a single arm. Enrolled patients will follow the protocol as described, including evaluation with MRI, echocardiography, and cardiopulmonary exercise testing.

Group Type: OTHER

MRI

Intervention Type: OTHER

Cardiac MRI

Interventions

MRI

Cardiac MRI

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kenneth Bilchick, MD

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Bilchick, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kenneth C Bilchick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kenneth C Bilchick, MD

Role: CONTACT

bilchick@virginia.edu

434-924-2465

Facility Contacts

Kenneth C Bilchick, MD

Role: primary

bilchick@virginia.edu

434-924-2465

References

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.

Reference Type: BACKGROUND

PMID: 28067978 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25581423 (View on PubMed)

Other Identifiers

MRIPOSTCRT

Identifier Type: -

Identifier Source: org_study_id