Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00661323

Collaborator

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

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemia Myocardial Infarction Ischemic Heart Disease

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 Design

Study Type:

Observational

Actual Enrollment :

1 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Left Ventricular Strain Quantification From 4D Echocardiography

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
1 Healthy volunteers will be recruited through the use of an approved study recruitment flyer.
2 Chemotherapy patients will be approached at the time of their nuclear scan to rule out cardiac disease prior to chemotherapy. These patients will be referred to the study by their doctor for the assessment of heart function.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)