HealthyNCT00720460
Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers
An observational study of Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will test new techniques to image the heart, blood vessels, and legs using magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments using minimally invasive methods. Healthy normal volunteers 18 years of age and older may be eligible for this study. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2008to 2 Nov 2018
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 1. GENERAL INCLUSION CRITERIA:
- Healthy adult volunteers, age is greater than 18 years of age, who consent to participate in writing
- EXCLUSION CRITERIA: MRI risk
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
- Implanted neural stimulator (e.g. TENS-Unit)
- Any type of ear or cochlear implant
- Intra-ocular foreign body (e.g. metal shavings)
- Any implanted device (e.g. insulin pump, drug infusion device)
- Metal shrapnel or bullet
- Morbid obesity
- Claustrophobia
- EXCLUSION CRITERIA: Contrast media risk:
- Pregnant women (when uncertain, subjects will undergo urine or blood testing) or lactating women
- Known hemoglobinopathy
- Known kidney disease
- Exposure to gadolinium MRI contrast agents in the past 18 hours, if the study requires gadolinium MRI contrast agent.
- Diabetes
- Children are not included.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Healthy Volunteers
This study will test new techniques to image the heart, blood vessels, and legs using magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments using minimally invasive methods.
Healthy normal volunteers 18 years of age and older may be eligible for this study.
Read more
For MRI, the subject lies flat on a table that can slide in and out of the scanner, a metal cyclinder. Special antennas, covered in pads, are placed against the subject s body. The scan time can vary from 20 minutes to 2 hours, with most scans lasting between 45 and 90 minutes. The subject may be asked to wear adhesive patches on the chest for monitoring the heart and a belt or finger pad for monitoring breathing. During the test, a contrast agent called gadolinium may be injected. This substance brightens the heart and arteries during the scan, providing a better picture of blood flow.
During the procedure, subjects may be asked to exercise their legs on a machine to evaluate the effects of motion and exercise on the MRI exam.
Large blood pressures cuffs may be placed on either or both thighs or calves to try to measure arterial flow to the legs. The cuffs are inflated to a pressure as high as at least 50 mmHg higher than thesubject s systolic blood pressure (up to 250 mmHg) for up to 10 minutes.
Subjects may be asked to return for repeated scans.
Read the detailed description
We will evaluate new developments in fast magnetic resonance imaging (MRI) of the heart and blood vessels on healthy volunteers. These studies will be conducted in the NIH MRI systems located at the NIH Clinical Center in Bethesda, Maryland. These procedures may involve the intravenous administration of commercially available MR contrast media, supine exercise or the inflation of blood pressure cuffs on the lower extremities during the MRI imaging. The results will be used to evaluate the performance of various research pulse sequences, gradient coils, and radiofrequency receiver coils on human subjects and will provide essential ground work for specific patient protocols, both diagnostic and therapeutic.
- Conditions
- Healthy
- Keywords
- Magnetic Resonance Imaging, Minimally Invasive Therapy, Transcatheter Therapeutics, Healthy Volunteers, Gadolinium Contrast, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and test new and incremental approaches to fast cardiovascular MRI in healthy human subjects. (healthy volunteers)
There are 24 objectives listed in the protocol as potential outcomes.
Measured: Day of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study start18 Jul 2008
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720460
- Sponsor's protocol ID
- 080185
- Other IDs
- 08-H-0185
- Status last verified
- 2 Nov 2018
- First submitted
- 19 Jul 2008
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Lederman RJ. Cardiovascular interventional magnetic resonance imaging. Circulation. 2005 Nov 8;112(19):3009-17. doi: 10.1161/CIRCULATIONAHA.104.531368. No abstract available.
PubMed 16275886Haustein J, Laniado M, Niendorf HP, Louton T, Beck W, Planitzer J, Schoffel M, Reiser M, Kaiser W, Schorner W, et al. Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients. Radiology. 1993 Mar;186(3):855-60. doi: 10.1148/radiology.186.3.8430199.
PubMed 8430199Niendorf HP, Haustein J, Cornelius I, Alhassan A, Clauss W. Safety of gadolinium-DTPA: extended clinical experience. Magn Reson Med. 1991 Dec;22(2):222-8; discussion 229-32. doi: 10.1002/mrm.1910220212.
PubMed 1812350Saybasili H, Kellman P, Griswold MA, Derbyshire JA, Guttman MA. HTGRAPPA: real-time B1-weighted image domain TGRAPPA reconstruction. Magn Reson Med. 2009 Jun;61(6):1425-33. doi: 10.1002/mrm.21922.
PubMed 19353673
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00720460
- Acronym / sponsor ID
- 080185
- Conditions
- Healthy
- Keywords
- Magnetic Resonance Imaging, Minimally Invasive Therapy, Transcatheter Therapeutics, Healthy Volunteers, Gadolinium Contrast, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 107 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 18 Jul 2008
- Study completion
- 2 Nov 2018
- First posted
- 22 Jul 2008 (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.
This study will test new techniques to image the heart, blood vessels, and legs using magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments using minimally invasive methods.
Healthy normal volunteers 18 years of age and older may be eligible for this study.
For MRI, the subject lies flat on a table that can slide in and out of the scanner, a metal cyclinder. Special antennas, covered in pads, are placed against the subject s body. The scan time can vary from 20 minutes to 2 hours, with most scans lasting between 45 and 90 minutes. The subject may be asked to wear adhesive patches on the chest for monitoring the heart and a belt or finger pad for monitoring breathing. During the test, a contrast agent called gadolinium may be injected. This substance brightens the heart and arteries during the scan, providing a better picture of blood flow.
During the procedure, subjects may be asked to exercise their legs on a machine to evaluate the effects of motion and exercise on the MRI exam.
Large blood pressures cuffs may be placed on either or both thighs or calves to try to measure arterial flow to the legs. The cuffs are inflated to a pressure as high as at least 50 mmHg higher than thesubject s systolic blood pressure (up to 250 mmHg) for up to 10 minutes.
Subjects may be asked to return for repeated scans.
Detailed description
We will evaluate new developments in fast magnetic resonance imaging (MRI) of the heart and blood vessels on healthy volunteers. These studies will be conducted in the NIH MRI systems located at the NIH Clinical Center in Bethesda, Maryland. These procedures may involve the intravenous administration of commercially available MR contrast media, supine exercise or the inflation of blood pressure cuffs on the lower extremities during the MRI imaging. The results will be used to evaluate the performance of various research pulse sequences, gradient coils, and radiofrequency receiver coils on human subjects and will provide essential ground work for specific patient protocols, both diagnostic and therapeutic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | –Healthy Volunteers |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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
To develop and test new and incremental approaches to fast cardiovascular MRI in healthy human subjects. (healthy volunteers)
Time frame: Day of study
There are 24 objectives listed in the protocol as potential outcomes.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 16275886Lederman RJ. Cardiovascular interventional magnetic resonance imaging. Circulation. 2005 Nov 8;112(19):3009-17. doi: 10.1161/CIRCULATIONAHA.104.531368. No abstract available.
- Background: PubMed 8430199Haustein J, Laniado M, Niendorf HP, Louton T, Beck W, Planitzer J, Schoffel M, Reiser M, Kaiser W, Schorner W, et al. Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients. Radiology. 1993 Mar;186(3):855-60. doi: 10.1148/radiology.186.3.8430199.
- Background: PubMed 1812350Niendorf HP, Haustein J, Cornelius I, Alhassan A, Clauss W. Safety of gadolinium-DTPA: extended clinical experience. Magn Reson Med. 1991 Dec;22(2):222-8; discussion 229-32. doi: 10.1002/mrm.1910220212.
- Derived from this study: PubMed 19353673Saybasili H, Kellman P, Griswold MA, Derbyshire JA, Guttman MA. HTGRAPPA: real-time B1-weighted image domain TGRAPPA reconstruction. Magn Reson Med. 2009 Jun;61(6):1425-33. doi: 10.1002/mrm.21922.
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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.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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 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?
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: stopped early, as of the sponsor's last update on 16 Dec 2019. 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 was stopped early. Results are not available in the source record.
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.
What does the primary outcome measure?
To develop and test new and incremental approaches to fast cardiovascular MRI in healthy human subjects. (healthy volunteers) (time frame: Day of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00720460, which also lists 4 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 16 Dec 2019.