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

NYU Langone Health logo

NYU Langone Health

Status

Suspended

Conditions

Magnetic Resonance Imaging (MRI)
Cardiac Resynchronization Therapy

Treatments

Procedure: Cardiac MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT02728336
14-01686

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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