Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Albert Sinusas, Yale University
ClinicalTrials.gov Identifier:
NCT00661323
First received: April 16, 2008
Last updated: January 29, 2013
Last verified: July 2009

April 16, 2008
January 29, 2013
July 2010
May 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00661323 on ClinicalTrials.gov Archive Site
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Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function
Left Ventricular Strain Quantification From 4D Echocardiography

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Participants will consist of two groups:

  1. Normal 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.
  • Ischemia
  • Myocardial Infarction
  • Ischemic Heart Disease
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  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2013
May 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact: Carol Akirav, MSc 203-737-5917 carol.akirav@yale.edu
Contact: Albert J. Sinusas, MD 203-785-3155 albert.sinusas@yale.edu
United States
 
NCT00661323
561, R01HL082640, R01 HL082640, 0608001734
No
Albert Sinusas, Yale University
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Albert J. Sinusas, MD Yale University
Yale University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP