Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy

June 30, 2017 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Magnetic resonance imaging (MRI) and spectroscopy are diagnostic tools that create high quality images of the human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields to create images of the body and organs. Occasionally, researchers will give patients undergoing a MRI an injection of a contrast substance. The contrast substance works by brightening areas of the magnetic resonance image.

In this study researchers plan to use magnetic resonance imaging with contrast substances and exercise on normal volunteers in order to evaluate different aspects of its performance. Information gathered from this study may be used to develop more specific research studies involving MRI....

Study Overview

Status

Completed

Conditions

Detailed Description

Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. These studies will be conducted in the NIH MRI systems located in Suburban Hospital in Bethesda, Maryland. These studies may involve the intravenous administration of commercially available MR contrast media and exercise. The results will be used to evaluate the performance of various pulse sequences, gradient coils, and RF coils on human subjects and will provide essential ground work for specific patient protocols.

Study Type

Observational

Enrollment

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Suburban Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

Any normal volunteer above the age 18 who is capable of giving informed consent will be included.

EXCLUSION CRITERIA:

A subject will be excluded if he/she has a contradiction to MR scanning.

  1. Brain aneurysm clip
  2. Implanted neural stimulator
  3. Implanted cardiac pacemaker implanted defibrillator
  4. Cochlear implant
  5. Ocular foreign body (e.g. metal shavings)
  6. Insulin pump
  7. Pregnant women (when uncertain, subjects will undergo urine or blood testing).
  8. Kidney
  9. Paralyzed hemidiaphragm
  10. Morbid obesity
  11. Claustrophobia
  12. Any condition in the PI's judgement which present unncessary risk

EXCLUSION CRITERIA FOR GADOLINIUM ENHANCED STUDIES:

  1. Lactating women
  2. Subjects with hemoglobinopathies
  3. Asthma
  4. Renal or hepatic disease

Subjects will be excluded if it is deemed that they have a condition that would preclude their use for technical development (e.g. paralyzed hemidiaphragm, morbid obesity, claustrophobia etc.) or present unnecessary risk (e.g. pregnancy, surgery of uncertain type, etc.).

Lactating women and subjects with hemoglobinopathies, asthma, or renal or hepatic disease will be excluded from studies involving the adminstration of contrast agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 22, 1999

Primary Completion (Actual)

August 3, 2009

Study Completion (Actual)

August 3, 2009

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

August 3, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 990048
  • 99-H-0048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe