Evaluation of the MRI in Measuring the Cardiac Chambers and Thoracic Great Vessels

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by State University of New York - Upstate Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00638664
First received: February 1, 2008
Last updated: April 26, 2011
Last verified: November 2008
  Purpose

We are seeking volunteers to participate in a research study to determine the optimal imaging parameters for visualization of the heart and its great vessels so that errors in computer data analysis is minimized and clinical accuracy is maximized.

Participation in this study will involve having an MRI of the heart. This study will allow us to determine the ability to measure the volumes of your heart chambers in both the left and right side of your heart without using any aggressive (invasive) technique or the use of ionizing radiation (x-rays or gamma rays). The study will also allow us to measure changes in the cardiac chamber volumes during the cardiac cycle and determine whether this can be done rapidly and accurately. The study will also allow us to determine whether this technique can be used for routine clinical use.


Condition
MRI

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Optimized MRI Evaluation of Maximal Temporal and Spatial Measurability of the Cardiac Chambers and Thoracic Great Vessels. A Comparison of MR Acquisition Pulse Sequences.

Further study details as provided by State University of New York - Upstate Medical University:

Estimated Enrollment: 300
Study Start Date: May 1995
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The ability to obtain accurate cyclical functional information of the cardiac chambers plays a continuing important clinical diagnostic role in the evaluation and monitoring of patients with a wide range of cardiac pathologies, including those embarking on or continuing cardiotoxic chemotherapeutic regimes, as well as patients with lung disease.

The current imaging modalities used for non-invasive imaging of the heart include echocardiography and radionuclide ventriculography. Echocardiographic evaluation of cardiac function is primarily limited to the left ventricle and functional measurements are based on volumetric estimates in turn based usually on geometric assumptions. That is, the volume calculation is based on a limited number of non orthogonal linear measurements assuming a regular (non complex) chamber morphology. This study technique provides no biologic hazard to the patient.

Radionuclide ventriculography does allow for 3D cardiac data acquisition and theoretical evaluation of biventricular function. However, the technique does not provide the same degree of spatial resolution that echocardiography can provide. Radionuclide ventriculography is a commonly accepted diagnostic procedure but does involve use of ionizing radiation.

Magnetic Resonance imaging techniques (of the heart) allows relatively high resolution cross sectional imaging. For example a 512X512 matrix over a 40cm field of view provides in plane resolution better that 1mm. No assumptions are made in regard chamber cross sectional area and hence volume morphology. The slice thickness is determined in advance and may be in the range of 1-10mm. MR data ca be acquired sequentially throughout the cardiac cycle and thus provide a time varying 3D map of the cardiac chambers and related structures during the cardiac cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Cardiology Clinic Center Watch Website

Criteria

Inclusion Criteria:

  • Over the age of 18 years
  • Able to understand and sign consent without surrogate signature
  • Subject weight is within the 300lb limit of the MR scanning table
  • Subject's bodily habitus allows the subject to fit within the MR bore
  • Subject being able to lie quiescent for a period of up to 60 minutes in a supine position
  • Subject would be able to hold breath at times for periods of 15-30 seconds

Exclusion Criteria:

  • Subjects with pacemakers, TENS units, metallic prostheses, metal foreign bodies such as bullets, shrapnel, metallic slivers, shavings or foreign bodies
  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: NCT00638664

Locations
United States, New York
University Radiology Associates
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: David Feiglin, MD SUNY Upstate MU
  More Information

No publications provided

Responsible Party: David Feiglin, MD, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00638664     History of Changes
Other Study ID Numbers: SUNYUMU 3149
Study First Received: February 1, 2008
Last Updated: April 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
conventional pulse sequences for MR
cardiac chambers and walls
cardio-thoracic vasculature
the great vessels
coronary vasculature
cardiac
great vessels

ClinicalTrials.gov processed this record on October 02, 2014