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Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03183011
Recruitment Status : Unknown
Verified June 2017 by Kenneth Bilchick, MD, University of Virginia.
Recruitment status was:  Recruiting
First Posted : June 9, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Kenneth Bilchick, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Other: MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
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.
Other: MRI
Cardiac MRI




Primary Outcome Measures :
  1. CRT Response [ Time Frame: 1 year ]
    CRT Response



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183011


Contacts
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Contact: Kenneth C Bilchick, MD 434-924-2465 bilchick@virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22901
Contact: Kenneth C Bilchick, MD    434-924-2465    bilchick@virginia.edu   
Sponsors and Collaborators
Kenneth Bilchick, MD
Investigators
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Principal Investigator: Kenneth C Bilchick, MD University of Virginia Health System
Publications:
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Responsible Party: Kenneth Bilchick, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03183011    
Other Study ID Numbers: MRIPOSTCRT
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenneth Bilchick, MD, University of Virginia:
cardiac resynchronization therapy
implantable cardioverter defibrillator
heart failure
magnetic resonance imaging
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases