Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00661323 |
Recruitment Status
:
Completed
First Posted
: April 18, 2008
Last Update Posted
: June 23, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Ischemia Myocardial Infarction Ischemic Heart Disease |
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 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 : | July 2010 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |
Group/Cohort |
---|
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.
|
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Participants will consist of two groups:
- Normal volunteers will be recruited through the use of an approved study recruitment flyer.
- 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.
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661323
United States, Connecticut | |
Yale University/Magnetic Resonance Research Center (MR-TAC)/Yale New Haven Hospital | |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Albert J. Sinusas, MD | Yale University |
Publications:
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT00661323 History of Changes |
Other Study ID Numbers: |
561 R01HL082640 ( U.S. NIH Grant/Contract ) 0608001734 |
First Posted: | April 18, 2008 Key Record Dates |
Last Update Posted: | June 23, 2016 |
Last Verified: | June 2016 |
Additional relevant MeSH terms:
Infarction Heart Diseases Myocardial Infarction Ischemia Myocardial Ischemia Coronary Artery Disease Pathologic Processes |
Necrosis Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |