Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function

NCT ID: NCT00661323

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Ischemia; Myocardial Infarction; Ischemic Heart Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Healthy volunteers will be recruited through the use of an approved study recruitment flyer.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert J. Sinusas, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University/Magnetic Resonance Research Center (MR-TAC)/Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

References

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. doi: 10.1002/mrm.1910320106.

Reference Type: BACKGROUND

PMID: 8084235 (View on PubMed)

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. doi: 10.1016/s0079-6107(98)00014-5.

Reference Type: BACKGROUND

PMID: 9785945 (View on PubMed)

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. doi: 10.1109/42.832958.

Reference Type: BACKGROUND

PMID: 10782617 (View on PubMed)

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. doi: 10.1016/s1361-8415(00)00022-0.

Reference Type: BACKGROUND

PMID: 11231174 (View on PubMed)

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. doi: 10.1152/ajpheart.2001.281.2.H698.

Reference Type: BACKGROUND

PMID: 11454574 (View on PubMed)

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. doi: 10.1109/42.511749.

Reference Type: BACKGROUND

PMID: 18215927 (View on PubMed)

Shi P, Sinusas AJ, Constable RT, Duncan JS. Volumetric deformation analysis using mechanics-based data fusion: Applications in cardiac motion recovery. International J Computer Vision 35:87-107, 1999

Reference Type: BACKGROUND

Other Identifiers

R01HL082640

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0608001734_B

Identifier Type: -

Identifier Source: org_study_id