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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03183011
Other study ID # MRIPOSTCRT
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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