Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00661323

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
Ischemia Myocardial Infarction Ischemic Heart Disease

MedlinePlus related topics: Heart Attack Heart Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Left Ventricular Strain Quantification From 4D Echocardiography

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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 [ Time Frame: Measured at participants' study visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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

Study Population

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.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661323

Contacts

Contact: Carol Akirav, MSc	203-785-2429	carol.akirav@yale.edu
Contact: Albert J. Sinusas, MD	203-785-3155	albert.sinusas@yale.edu

Locations

United States, Connecticut
Yale University/Magnetic Resonance Research Center (MR-TAC)/Yale New Haven Hospital
New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Albert J. Sinusas, MD

Yale University

More Information

Publications:

Constable RT, Rath KM, Sinusas AJ, Gore JC. Development and evaluation of tracking algorithms for cardiac wall motion analysis using phase velocity MR imaging. Magn Reson Med. 1994 Jul;32(1):33-42.

Duncan J, Shi P, Constable T, Sinusas A. Physical and geometrical modeling for image-based recovery of left ventricular deformation. Prog Biophys Mol Biol. 1998;69(2-3):333-51. Review.

Shi P, Sinusas AJ, Constable RT, Ritman E, Duncan JS. Point-tracked quantitative analysis of left ventricular surface motion from 3-D image sequences. IEEE Trans Med Imaging. 2000 Jan;19(1):36-50.

Papademetris X, Sinusas AJ, Dione DP, Duncan JS. Estimation of 3D left ventricular deformation from echocardiography. Med Image Anal. 2001 Mar;5(1):17-28.

Sinusas AJ, Papademetris X, Constable RT, Dione DP, Slade MD, Shi P, Duncan JS. Quantification of 3-D regional myocardial deformation: shape-based analysis of magnetic resonance images. Am J Physiol Heart Circ Physiol. 2001 Aug;281(2):H698-714.

Meyer FG, Constable RT, Sinusas AJ, Duncan JS. Tracking myocardial deformation using phase contrast MR velocity fields: a stochastic approach. IEEE Trans Med Imaging. 1996;15(4):453-65.

Responsible Party:	Yale University ( Dr. Albert Sinusas, Professor of Internal Medicine & Diagnostic Radiology )
Study ID Numbers:	561, R01 HL082640, 0608001734
Study First Received:	April 16, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00661323
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009