Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

Not Applicable

Suspended

• Conditions: Heart Disease
• Interventions: Procedure: cardiovascular MRI (CMR); Procedure: Conventional Cardiologic Evaluation

• Registration Number: NCT02728284
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-30
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Study Start: 2018-03-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Cardiovascular System	cardiovascular MRI (CMR)	70 with a history of heart or lung disease
Abnormal Cardiovascular System	Conventional Cardiologic Evaluation	30 without any history of heart or lung disease

Primary Outcome Measures

Name	Time	Method
Image Quality measured by signal to noise	10 Minutes
Suitability for routine use measured by imaging time and ease of use	10 Minutes
Image Quality measured by resolution	10 Minutes

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States