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Completed

NCT Number: NCT00661323

Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University/Magnetic Resonance Research Center (MR-TAC)/Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Establish baseline strain patterns for future studies evaluating alterations in left ventricular strain/strain rates associated with regional myocardial ischemia and injury

    Time frame: Measured at participants' study visit

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Left Ventricular Strain Quantification From 4D Echocardiography

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2008
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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