Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias

Cardiac Arrythmias Clinical Trial

Official title:

Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02741180
• Other study ID #: 15-00116
• Status: Suspended
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 135
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrythmias

Intervention

Other:
• 3D Imaging
"roadmapping" of electrophysiology (EP) procedures
• Late Gadolinium Enhancement (LGE)
useful for delineating abnormal myocardium, including fibrotic regions that can serve as sources of arrhythmias.

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	Paired-sample Wilcoxon signed rank test to evaluate measures on Likert scales		3 Years
Primary	Paired-sample t tests for quantitative measures of intensity of image artifacts		3 Years