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

NCT02728336 | Suspended DMC

• 1 other identifier: 14-01686
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronization Therapy; Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• Derivation of score of patient suitability for CRT

  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.

  4 Years

Study Arms (2)

Heart Failure Patients

ACTIVE COMPARATOR

patients who are scheduled to undergo clinically ordered CRT for heart failure complicated by dyssynchrony

Procedure: Cardiac MRI

Control

ACTIVE COMPARATOR

20 matched control subjects

Procedure: Cardiac MRI

Interventions

Cardiac MRI PROCEDURE

Control; Heart Failure Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

• Leon Axel, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 5, 2016
• Study Start: November 1, 2014
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)