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

Sponsor

NYU Langone Health (Other)

Overall Status

Suspended

CT.gov ID

NCT02728336

Collaborator

(none)

110

Enrollment

Location

Arms

117

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2014

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Leon Axel, MD, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02728336

Other Study ID Numbers:

14-01686

First Posted:

Apr 5, 2016

Last Update Posted:

Jul 7, 2022

Last Verified:

Jul 1, 2022

Study Results

No Results Posted as of Jul 7, 2022