Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function
Recruitment status was Recruiting
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Purpose
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 |
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Ischemia Myocardial Infarction Ischemic Heart Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Left Ventricular Strain Quantification From 4D Echocardiography |
- 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 ]
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
Healthy volunteers will be recruited through the use of an approved study recruitment flyer.
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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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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)
Contacts and Locations| 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, Connecticut | |
| Yale University/Magnetic Resonance Research Center (MR-TAC)/Yale New Haven Hospital | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Contact: Albert J. Sinusas, MD 203-785-3155 albert.sinusas@yale.edu | |
| Sub-Investigator: James Duncan, PhD | |
| Principal Investigator: | Albert J. Sinusas, MD | Yale University |
More Information
Publications:
| Responsible Party: | Albert Sinusas, Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00661323 History of Changes |
| Other Study ID Numbers: | 561, R01HL082640, R01 HL082640, 0608001734 |
| Study First Received: | April 16, 2008 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Coronary Disease Cardiovascular Diseases Arterial Occlusive Diseases Vascular Diseases |
Infarction Ischemia Myocardial Infarction Arteriosclerosis Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 16, 2013