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Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

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ClinicalTrials.gov Identifier: NCT02728284
Recruitment Status : Suspended (COVID-19)
First Posted : April 5, 2016
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Disease Procedure: cardiovascular MRI (CMR) Procedure: Conventional Cardiologic Evaluation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Normal Cardiovascular System
70 with a history of heart or lung disease
 Procedure: cardiovascular MRI (CMR)
CMR is used to demonstrate cardiac abnormalities and assess cardiac function in many patients
Active Comparator: Abnormal Cardiovascular System
30 without any history of heart or lung disease
 Procedure: Conventional Cardiologic Evaluation
ECG (gating), and respiratory motion effects


Outcome Measures
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Primary Outcome Measures :
  1. Image Quality measured by resolution [ Time Frame: 10 Minutes ]
  2. Image Quality measured by signal to noise [ Time Frame: 10 Minutes ]
  3. Suitability for routine use measured by imaging time and ease of use [ Time Frame: 10 Minutes ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728284


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Leon Axel New York University Medical School
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02728284    
Other Study ID Numbers: 14-00601
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Magnetic Resonance Imaging (MRI)
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases