Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

NCT03183011 | Unknown DMC

• 1 other identifier: MRIPOSTCRT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Systolic

Keywords

cardiac resynchronization therapy; implantable cardioverter defibrillator; heart failure; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• CRT Response

  CRT Response

  1 year

Study Arms (1)

Post-CRT MRI

OTHER

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

Other: MRI

Interventions

MRI OTHER

Cardiac MRI

Post-CRT MRI

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic systolic HF
• LVEF 35% or less
• Guideline-based class I or IIa indication for CRT
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenneth Bilchick, MD: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22901, United States

RECRUITING

Related 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 Sep;46(3):887-896. doi: 10.1002/jmri.25613. Epub 2017 Jan 9.

  PMID: 28067978 BACKGROUND

• 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.

  PMID: 25581423 BACKGROUND

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kenneth C Bilchick, MD

  University of Virginia Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth C Bilchick, MD

CONTACT

434-924-2465; bilchick@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: November 1, 2016
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)