Back to resultsEvaluation of Cardiac Function With Cardio-respiratory Synchronized MRI
Primary Purpose
Heart Disease
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cardiovascular MRI (CMR)
Conventional Cardiologic Evaluation
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Disease focused on measuring Magnetic Resonance Imaging (MRI)
Eligibility Criteria
Inclusion Criteria:
- Subjects will be selected as they are scheduled for clinical MR examinations.
- Subjects will be selected on the basis of their willingness and ability to participate, on their comprehension of the informed consent document, on their likelihood of completing the study, and on the clinical appropriateness of the investigational technique for a given patient.
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
- pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Normal Cardiovascular System
Abnormal Cardiovascular System
Arm Description
70 with a history of heart or lung disease
30 without any history of heart or lung disease
Outcomes
Primary Outcome Measures
Image Quality measured by resolution
Image Quality measured by signal to noise
Suitability for routine use measured by imaging time and ease of use
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02728284
Brief Title
Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI
Official Title
Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Why Stopped
COVID-19
Study Start Date
March 29, 2018 (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
Yes
5. Study Description
Brief Summary
The purpose of this investigation is to evaluate newer methods of performing cardiovascular MRI (CMR) that will provide new kinds of information related to the interplay between the cardiac and the respiratory cycles, such as the interaction between the left ventricle and the right ventricle during respiration . The primary statistical objective is to provide preliminary indications of the relative utility of the investigational imaging software in terms of image quality and suitability for routine clinical use. Image quality will be expressed in terms of signal-to-noise ratios (SNR), contrast-to-noise ratios (CNR) and subjective Likert-type qualitative assessments independently provided by each of multiple blinded readers for each image. Suitability for routine use will be assessed in terms of imaging time and a binary indicator of whether, in the opinion of the investigator, adverse procedural complications (not expected) were encountered during a given imaging session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease
Keywords
Magnetic Resonance Imaging (MRI)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal Cardiovascular System
Arm Type
Active Comparator
Arm Description
70 with a history of heart or lung disease
Arm Title
Abnormal Cardiovascular System
Arm Type
Active Comparator
Arm Description
30 without any history of heart or lung disease
Intervention Type
Procedure
Intervention Name(s)
cardiovascular MRI (CMR)
Intervention Description
CMR is used to demonstrate cardiac abnormalities and assess cardiac function in many patients
Intervention Type
Procedure
Intervention Name(s)
Conventional Cardiologic Evaluation
Intervention Description
ECG (gating), and respiratory motion effects
Primary Outcome Measure Information:
Title
Image Quality measured by resolution
Time Frame
10 Minutes
Title
Image Quality measured by signal to noise
Time Frame
10 Minutes
Title
Suitability for routine use measured by imaging time and ease of use
Time Frame
10 Minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will be selected as they are scheduled for clinical MR examinations.
Subjects will be selected on the basis of their willingness and ability to participate, on their comprehension of the informed consent document, on their likelihood of completing the study, and on the clinical appropriateness of the investigational technique for a given patient.
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
pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Axel
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
Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI
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