Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI

NCT02728284 | Suspended DMC

• 1 other identifier: 14-00601
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (3)

• Image Quality measured by resolution

  10 Minutes

• Image Quality measured by signal to noise

  10 Minutes

• Suitability for routine use measured by imaging time and ease of use

  10 Minutes

Study Arms (2)

Normal Cardiovascular System

ACTIVE COMPARATOR

70 with a history of heart or lung disease

Procedure: cardiovascular MRI (CMR)

Abnormal Cardiovascular System

ACTIVE COMPARATOR

30 without any history of heart or lung disease

Procedure: Conventional Cardiologic Evaluation

Interventions

cardiovascular MRI (CMR) PROCEDURE

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

Normal Cardiovascular System

Conventional Cardiologic Evaluation PROCEDURE

ECG (gating), and respiratory motion effects

Abnormal Cardiovascular System

Eligibility Criteria

• Age: 7 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Leon Axel

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 5, 2016
• Study Start: March 29, 2018
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

US (1)