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

Not Applicable

Suspended

• Conditions: Cardiac Resynchronization Therapy; Magnetic Resonance Imaging (MRI)
• Interventions: Procedure: Cardiac MRI

• Registration Number: NCT02728336
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heart Failure Patients	Cardiac MRI	patients who are scheduled to undergo clinically ordered CRT for heart failure complicated by dyssynchrony
Control	Cardiac MRI	20 matched control subjects

Primary Outcome Measures

Name	Time	Method
Derivation of score of patient suitability for CRT	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States