Cardiovascular DiseaseNCT00001874
Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy
An observational study of Cardiovascular Disease and Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Healthy
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 1999to 3 Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any normal volunteer above the age 18 who is capable of giving informed consent will be included.
Who cannot join
- A subject will be excluded if he/she has a contradiction to MR scanning.
- Brain aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker implanted defibrillator
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
Show all 19Show fewer
- Insulin pump
- Pregnant women (when uncertain, subjects will undergo urine or blood testing).
- Kidney
- Paralyzed hemidiaphragm
- Morbid obesity
- Claustrophobia
- Any condition in the PI's judgement which present unncessary risk
- Lactating women
- Subjects with hemoglobinopathies
- Asthma
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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....
Read the 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.
- Conditions
- Cardiovascular Disease, Healthy
- Keywords
- Imaging, Spectroscopy, MRI, Cardiovascular, Technical Development, Safety, Gadolinium, Heart, Toxicity, Adverse Events, Normal Volunteer
- Medical subject headings
- Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start22 Feb 1999
- Primary completion3 Aug 2009
- Study completion3 Aug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 400 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001874
- Sponsor's protocol ID
- 990048
- Other IDs
- 99-H-0048
- Status last verified
- 3 Aug 2009
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.
PubMed 7928216Mattay VS, Weinberger DR, Barrios FA, Sobering GS, Kotrla KJ, van Gelderen P, Duyn JH, Sexton RH, Moonen CT, Frank JA. Brain mapping with functional MR imaging: comparison of gradient-echo--based exogenous and endogenous contrast techniques. Radiology. 1995 Mar;194(3):687-91. doi: 10.1148/radiology.194.3.7862963.
PubMed 7862963Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.
PubMed 1889423
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy
- ClinicalTrials.gov ID
- NCT00001874
- Acronym / sponsor ID
- 990048
- Conditions
- Cardiovascular Disease, Healthy
- Keywords
- Imaging, Spectroscopy, MRI, Cardiovascular, Technical Development, Safety, Gadolinium, Heart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 22 Feb 1999
- Primary completion
- 3 Aug 2009 (actual)
- Study completion
- 3 Aug 2009 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any normal volunteer above the age 18 who is capable of giving informed consent will be included.
Key exclusion criteria (19 listed)
- A subject will be excluded if he/she has a contradiction to MR scanning.
- Brain aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker implanted defibrillator
- Cochlear implant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 7928216Frank JA, Mattay VS, Duyn J, Sobering G, Barrios FA, Zigun J, Sexton R, Kwok P, Woo J, Moonen C, et al. Measurement of relative cerebral blood volume changes with visual stimulation by 'double-dose' gadopentetate-dimeglumine-enhanced dynamic magnetic resonance imaging. Invest Radiol. 1994 Jun;29 Suppl 2:S157-60. doi: 10.1097/00004424-199406001-00052. No abstract available.
- Background: PubMed 7862963Mattay VS, Weinberger DR, Barrios FA, Sobering GS, Kotrla KJ, van Gelderen P, Duyn JH, Sexton RH, Moonen CT, Frank JA. Brain mapping with functional MR imaging: comparison of gradient-echo--based exogenous and endogenous contrast techniques. Radiology. 1995 Mar;194(3):687-91. doi: 10.1148/radiology.194.3.7862963.
- Background: PubMed 1889423Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001874, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.