Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function

NCT00661323 | Completed

• 2 other identifiers: 0608001734_BR01HL082640
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia; Myocardial Infarction; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Establish baseline strain patterns for future studies evaluating alterations in left ventricular strain/strain rates associated with regional myocardial ischemia and injury

  Measured at participants' study visit

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• No evidence of underlying cardiac disease based on history or electrocardiogram (ECG)
• Adequate intravenous access in one arm

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

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

New Haven, Connecticut, 06520, United States

Location

Related Publications (7)

• 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.

  PMID: 8084235 BACKGROUND

• 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.

  PMID: 9785945 BACKGROUND

• 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.

  PMID: 10782617 BACKGROUND

• 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.

  PMID: 11231174 BACKGROUND

• 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.

  PMID: 11454574 BACKGROUND

• 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.

  PMID: 18215927 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Ischemia; Myocardial Infarction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Necrosis

Study Officials

• Albert J. Sinusas, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: July 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 30, 2020

Record last verified: 2016-06

Locations

US (1)