Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias

September 19, 2023 updated by: NYU Langone Health
The primary purpose of this study is to improve the quality of Magnetic Resonance Imaging in patients with heart arrhythmia. Investigators will recruit 105 patients with arrhythmia and 30 control volunteers over 3 years and will use two arrhythmia-tolerant imaging methods for diagnosis.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

In the proposed research, investigators will extend conventional cardiac magnetic resonance methods to enable the creation of high-quality cine CMR images in the presence of multiple kinds of arrhythmia. Two arrhythmia-tolerant imaging methods will be adopted, which are particularly useful in arrhythmia: 1) 3D imaging, which is useful for many purposes, including "road mapping" of electrophysiology (EP) procedures, and 2) late gadolinium enhancement (LGE), which is useful for delineating abnormal myocardium, including fibrotic regions that can serve as sources of arrhythmias.

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 83 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for Arrhythmia Patients:

  • Patients diagnosed with heart arrhythmia scheduled for routine clinical MRI examinations).
  • Patients scheduled for routine clinical MRI examinations who do not have a specific known diagnosis of arrhythmia, but who may be found to have image degradation due to arrhythmia during the CMR examination.

Inclusion Criteria for Controls:

  • No history of heart arrhythmia.

Exclusion Criteria for Patients and Controls:

  • Hemodynamic instability.
  • Contraindications for MRI examinations (e.g., pacemakers or ferromagnetic vascular clips).

  • History of prior cardiovascular disease or significant risk factors:

    • Diabetes, hypertension, smoking, and hyperlipidemia, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy Control
Other: 3D Imaging
"roadmapping" of electrophysiology (EP) procedures
Other: Late Gadolinium Enhancement (LGE)
useful for delineating abnormal myocardium, including fibrotic regions that can serve as sources of arrhythmias.
Other: Patients with Arrhythmias
Other: 3D Imaging
"roadmapping" of electrophysiology (EP) procedures
Other: Late Gadolinium Enhancement (LGE)
useful for delineating abnormal myocardium, including fibrotic regions that can serve as sources of arrhythmias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Paired-sample Wilcoxon signed rank test to evaluate measures on Likert scales
Time Frame: 3 Years
3 Years
Paired-sample t tests for quantitative measures of intensity of image artifacts
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2017

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimated)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00116

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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