Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias

NCT02741180 | Suspended

• 1 other identifier: 15-00116
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrythmias

Outcome Measures

Primary Outcomes (2)

• Paired-sample Wilcoxon signed rank test to evaluate measures on Likert scales

  3 Years

• Paired-sample t tests for quantitative measures of intensity of image artifacts

  3 Years

Study Arms (2)

Patients with Arrhythmias

OTHER

Other: 3D Imaging; Other: Late Gadolinium Enhancement (LGE)

Healthy Control

OTHER

Other: 3D Imaging; Other: Late Gadolinium Enhancement (LGE)

Interventions

3D Imaging OTHER

"roadmapping" of electrophysiology (EP) procedures

Healthy Control; Patients with Arrhythmias

Late Gadolinium Enhancement (LGE) OTHER

useful for delineating abnormal myocardium, including fibrotic regions that can serve as sources of arrhythmias.

Healthy Control; Patients with Arrhythmias

Eligibility Criteria

• Age: 10 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No history of heart arrhythmia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Imaging, Three-Dimensional

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

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 29, 2016
• First Posted: April 18, 2016
• Study Start: September 29, 2017
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

US (1)