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MRI Assessment of Patient Suitability for Cardiac Resynchronization Therapy (CRT)

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: NCT02728336
Recruitment Status : Suspended (COVID-19)
First Posted : April 5, 2016
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The goals of this project are to: 1) explore the potential use of magnetic resonance imaging (MRI) data for improved prediction of response to cardiac resynchronization (CRT), and 2) use the MRI-derived data together with a computer model of the cardiovascular system to study the relative roles of different factors in the mechanical effects of dyssynchrony in failure, and in the response (or lack thereof) to CRT.

Condition or disease Intervention/treatment Phase
Cardiac Resynchronization Therapy Magnetic Resonance Imaging (MRI) Procedure: Cardiac MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI Assessment of Patient Suitability for Cardiac Resynchronization Therapy (CRT)
Actual Study Start Date : November 2014
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Arm Intervention/treatment
Active Comparator: Heart Failure Patients
patients who are scheduled to undergo clinically ordered CRT for heart failure complicated by dyssynchrony
Procedure: Cardiac MRI
Active Comparator: Control
20 matched control subjects
Procedure: Cardiac MRI



Primary Outcome Measures :
  1. Derivation of score of patient suitability for CRT [ Time Frame: 4 Years ]
    Binary logistic regression and receiver operating characteristic curve (ROC) analyses will be used to assess the utility of baseline (pre-CRT) MRI-derived measures, alone and in combination, for the prediction of response to CRT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female patients ages 18 and over scheduled by conventional criteria (symptomatic impairment of cardiac function with broadened QRS) for clinical CRT procedures at NYULMC.
  • Normal kidney function as determined by GFR levels.

Inclusion Criteria for Controls

  • Normal kidney function as determined by GFR levels
  • No significant cardiovascular disease or risk factors.

Exclusion Criteria:

  • electrical implants such as cardiac pacemakers or perfusion pumps
  • ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
  • ferromagnetic objects such as jewelry or metal clips in clothing (which will be removed)
  • pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.

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): NCT02728336


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Leon Axel, MD New York University Medical School
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02728336    
Other Study ID Numbers: 14-01686
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020