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

Cardiac Resynchronization Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02728336
• Other study ID #: 14-01686
• Status: Suspended
• Phase: N/A
• Start date: November 2014
• Est. completion date: August 2026

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 110
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Magnetic Resonance Imaging (MRI)

Intervention

Procedure:
• Cardiac MRI

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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