Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy

June 8, 2017 updated by: Kenneth Bilchick, MD
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22901
        • Recruiting
        • University of Virginia Health System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRT Response
Time Frame: 1 year
CRT Response
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth Bilchick, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

October 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRIPOSTCRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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