Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

Heart Failure, Systolic Clinical Trial

Official title:

Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03183011
• Other study ID #: MRIPOSTCRT
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2017
• Last updated: June 8, 2017
• Start date: November 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2017
• Source: University of Virginia
• Contact: Kenneth C Bilchick, MD
• Phone: 434-924-2465
• Email: bilchick[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Other:
• MRI
Cardiac MRI

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Kenneth Bilchick, MD

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Jan 9. doi: 10.1002/jmri.25613. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRT Response	CRT Response	1 year