Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

Heart Disease Clinical Trial

Official title:

Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02728284
• Other study ID #: 14-00601
• Status: Suspended
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Intervention

Procedure:
• cardiovascular MRI (CMR)
CMR is used to demonstrate cardiac abnormalities and assess cardiac function in many patients
• Conventional Cardiologic Evaluation
ECG (gating), and respiratory motion effects

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image Quality measured by resolution		10 Minutes
Primary	Image Quality measured by signal to noise		10 Minutes
Primary	Suitability for routine use measured by imaging time and ease of use		10 Minutes