Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

Conditions
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Heart Disease

Intervention / Treatment
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* Procedure: cardiovascular MRI (CMR)
* Procedure: Conventional Cardiologic Evaluation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Cardiovascular System<br>70 with a history of heart or lung disease | Procedure: cardiovascular MRI (CMR)<br>* CMR is used to demonstrate cardiac abnormalities and assess cardiac function in many patients<br>|
| Active Comparator: Abnormal Cardiovascular System<br>30 without any history of heart or lung disease | Procedure: Conventional Cardiologic Evaluation<br>* ECG (gating), and respiratory motion effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality measured by resolution |  | 10 Minutes | 
| Image Quality measured by signal to noise |  | 10 Minutes | 
| Suitability for routine use measured by imaging time and ease of use |  | 10 Minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging (MRI)