Back to resultsSparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias
Primary Purpose
Cardiac Arrythmias
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D Imaging
Late Gadolinium Enhancement (LGE)
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrythmias
Eligibility Criteria
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients with Arrhythmias
Healthy Control
Arm Description
Outcomes
Primary Outcome Measures
Paired-sample Wilcoxon signed rank test to evaluate measures on Likert scales
Paired-sample t tests for quantitative measures of intensity of image artifacts
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02741180
Brief Title
Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias
Official Title
Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
COVID-19
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrythmias
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with Arrhythmias
Arm Type
Other
Arm Title
Healthy Control
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
3D Imaging
Intervention Description
"roadmapping" of electrophysiology (EP) procedures
Intervention Type
Other
Intervention Name(s)
Late Gadolinium Enhancement (LGE)
Intervention Description
useful for delineating abnormal myocardium, including fibrotic regions that can serve as sources of arrhythmias.
Primary Outcome Measure Information:
Title
Paired-sample Wilcoxon signed rank test to evaluate measures on Likert scales
Time Frame
3 Years
Title
Paired-sample t tests for quantitative measures of intensity of image artifacts
Time Frame
3 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Axel, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Sparsity-based Magnetic Resonance Imaging of Cardiac Arrhythmias
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