Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

NCT ID: NCT02728284

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2027-08-31

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.

Conditions

Heart Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Normal Cardiovascular System

70 with a history of heart or lung disease

Group Type: ACTIVE_COMPARATOR

cardiovascular MRI (CMR)

Intervention Type: PROCEDURE

CMR is used to demonstrate cardiac abnormalities and assess cardiac function in many patients

Abnormal Cardiovascular System

30 without any history of heart or lung disease

Group Type: ACTIVE_COMPARATOR

Conventional Cardiologic Evaluation

Intervention Type: PROCEDURE

ECG (gating), and respiratory motion effects

Interventions

cardiovascular MRI (CMR)

CMR is used to demonstrate cardiac abnormalities and assess cardiac function in many patients

Intervention Type: PROCEDURE

Conventional Cardiologic Evaluation

ECG (gating), and respiratory motion effects

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leon Axel

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

14-00601

Identifier Type: -

Identifier Source: org_study_id