Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function

Completed

• Conditions: Ischemia; Myocardial Infarction; Ischemic Heart Disease

• Registration Number: NCT00661323
• Lead Sponsor: Yale University

Brief Summary

Magnetic resonance imaging (MRI) and echocardiography are two imaging methods that are used to obtain pictures of the heart and assess heart function. This study will evaluate a new, four-dimensional echocardiography approach of obtaining heart images to determine if it is as effective at evaluating heart function as MRI.

Detailed Description

MRI is a non-invasive method of obtaining images of the body. An MRI is conducted by having a person lie down on a narrow table, which then slides into a large tunnel-like tube. Powerful magnets and radio waves scan the body and a computer records the resulting signals. An echocardiography is a non-invasive ultrasound test that uses sound waves to create images of the heart. It is performed by having a doctor move a wand-like device over a patient's chest. The device then converts sound waves into pictures of the heart. Currently, a special MRI technique is used to evaluate heart function; however, MRI is expensive and cannot be used on critically ill patients. Echocardiography can be performed at a patient's bedside and it may be a more effective way of assessing heart function. The purpose of this study is to determine the effectiveness of a new four-dimensional echocardiography approach at evaluating heart function. Results from this study may be used to diagnose and treat patients more effectively in the future.

This study will enroll healthy people who do not have heart disease and people who are receiving chemotherapy who do not have heart disease. Participants will have a physical examination and a medical records review. MRI scans and a four-dimensional echocardiography of the heart will be performed. There will be no additional study visits.

Study Timeline

• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-18
• Study Start: 2010-07
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-06
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• No evidence of underlying cardiac disease based on history or electrocardiogram (ECG)
• Adequate intravenous access in one arm

Exclusion Criteria

• Pregnant or breastfeeding; if pre-menopausal, not practicing acceptable method of birth control
• History of any other medical condition that is likely to hinder study conduct or pose a safety concern, in the opinion of the investigator
• History of cardiac disease, including heart attack or heart valve disease
• Uncontrolled high blood pressure, defined as systolic blood pressure higher than 160 mm Hg and/or diastolic pressure higher than 100 mm Hg
• Abnormal ECG or chest pain syndrome
• Claustrophobia
• Resting heart rate greater than 110 bpm
• Unable to undergo MRI procedure (e.g., pacemaker, metallic implants)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish baseline strain patterns for future studies evaluating alterations in left ventricular strain/strain rates associated with regional myocardial ischemia and injury	Measured at participants' study visit

Trial Locations

Locations (1)

Yale University/Magnetic Resonance Research Center (MR-TAC)/Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States