Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

NYU Langone Health

Status

Suspended

Conditions

Heart Disease

Treatments

Procedure: Conventional Cardiologic Evaluation

Procedure: cardiovascular MRI (CMR)

Study type

Interventional

Funder types

Other

Identifiers

NCT02728284

14-00601

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

7 to 95 years old

Volunteers

No Healthy Volunteers

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.