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Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

Primary Purpose

Heart Failure, Systolic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
Kenneth Bilchick, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure, Systolic focused on measuring cardiac resynchronization therapy, implantable cardioverter defibrillator, heart failure, magnetic resonance imaging

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Post-CRT MRI

Arm Description

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

Outcomes

Primary Outcome Measures

CRT Response
CRT Response

Secondary Outcome Measures

Full Information

First Posted
June 7, 2017
Last Updated
June 8, 2017
Sponsor
Kenneth Bilchick, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03183011
Brief Title
Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy
Official Title
Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Bilchick, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
cardiac resynchronization therapy, implantable cardioverter defibrillator, heart failure, magnetic resonance imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Post-CRT MRI
Arm Type
Other
Arm Description
This study has a single arm. Enrolled patients will follow the protocol as described, including evaluation with MRI, echocardiography, and cardiopulmonary exercise testing.
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Cardiac MRI
Primary Outcome Measure Information:
Title
CRT Response
Description
CRT Response
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth C Bilchick, MD
Phone
434-924-2465
Email
bilchick@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth C Bilchick, MD
Organizational Affiliation
University of Virginia Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth C Bilchick, MD
Phone
434-924-2465
Email
bilchick@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28067978
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.
Results Reference
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PubMed Identifier
25581423
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.
Results Reference
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Learn more about this trial

Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

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