Evaluating a New Echocardiography Imaging Procedure for Evaluating Heart Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Albert Sinusas, Yale University
ClinicalTrials.gov Identifier:
NCT00661323
First received: April 16, 2008
Last updated: January 29, 2013
Last verified: July 2009
  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

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

Resource links provided by NLM:


Further study details as provided by Yale University:

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 ]

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
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:

  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.
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
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, see Learn About Clinical Studies.

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

Contacts
Contact: Carol Akirav, MSc 203-737-5917 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 Recruiting
New Haven, Connecticut, United States, 06520
Contact: Albert J. Sinusas, MD    203-785-3155    albert.sinusas@yale.edu   
Sub-Investigator: James Duncan, PhD         
Sponsors and Collaborators
Yale University
Investigators
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
Infarction
Ischemia
Myocardial Infarction
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 10, 2014