Cardiac Risk FactorsNCT01130545
Imaging Techniques in MRI
An observational study of Cardiac Risk Factors and Healthy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Magnetic resonance imaging (MRI) scans must be performed according to specified sets of parameters that provide optimal images of each organ and each area of the body. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Risk Factors, Healthy, Healthy Volunteers
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2010to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers (maybe Volunteers, NIH employee and current NIH protocol participants)
Who may be able to join
- Volunteer individuals
- Lab Eligibility parameters (for contrast scans within 4 weeks of gadolinium injection):
- Creatinine below upper normal limit
- eGFR >= 60 mL/min/1.73m2
- Age >= 60 or history of renal disease: test GFR within 1 week prior to contrast
- Willing to travel to the NIH for follow-up visits.
Show all 9Show fewer
- 18 years old
- Able to understand and sign informed consent
- No MRI scan with gadolinium injection in the last 6 months under this protocol.
Who cannot join
- Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples:
- Aneurysm clip, implanted neural stimulator,
- Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices,
- Cochlear implant, ocular foreign body (metal shavings),
- Any implanted device (pumps, infusion devices, etc.),
- Shrapnel injuries,
Show all 21Show fewer
- History of metal in head or eyes or other parts of the body.
- Pregnant women
- Paralyzed hemidiaphragm
- Over 500 lbs and/or a body circumference that prevents the study subject from laying flat in the scanner
- Surgery of uncertain type
- Untreatable claustrophobia otherwise requiring anesthesia.
- Any contraindications that the Physician identifies from the subject, MRI Safety Questionnaire, and/or History and Physical.
- (Inclusive of the above exclusion criteria):
- Allergy to gadolinium for scans using contrast; will be eligible for non-contrast scans.
- Acute renal failure, renal transplant, dialysis and renal failure individuals (eGFR <60 mL/min/1.73m2 and/or clinically diagnosed).
- Individuals with a history of liver transplant or severe liver disease.
- Lactating women
- Individuals with hemoglobinopathies or severe asthma.
- Patient preference to not undergo intravenous line placement and/or receive gadolinium contrast. Contrast administration is optional and participants may still undergo a non-contrast study.
- GBCA with an MRI scan in the last 6 months. This includes scan performed with GBCA at any outside institution and / or at the clinical center .In addition, they cannot have reached their maximum of 4 GBCA imaging studies under this protocol. They will be excluded from having a contrast enhanced MRI, but will not be excluded from the protocol for non-contrast MRI studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Magnetic resonance imaging (MRI) scans must be performed according to specified sets of parameters that provide optimal images of each organ and each area of the body. These scanning parameters are often specific to the institution or organization at which they are employed, and may also depend on the manufacturer of the MRI scanning equipment. Because MRI scanning equipment is always being updated and upgraded, researchers are interested in developing new and optimized scanning parameters for MRI scans.
Read more
Objectives:
- To improve current methods and develop new techniques for magnetic resonance imaging.
Eligibility:
- Individuals 18 years of age and older who are either volunteers or current NIH protocol participants.
- Participants must not have any medical history factors (e.g., extreme claustrophobia, history of metal implants) that would prevent them from receiving MRI scans.
Design:
- Participants will have at least one MRI scan that will last from 20 minutes to 2 hours (most scans will last between 45 and 90 minutes). The total time commitment for most visits will be approximately 4 hours from start to finish.
- Some MRI techniques require standard monitoring equipment or specific procedures during the scanning, such as an electrocardiogram.
- Participants will have blood samples taken at the time of the scan. Some MRI studies will require the use of a contrast agent that will be administered during the scan.
- Volunteers may be asked to return for additional MRI scans over the course of a few years. Follow-up scans may be done on the same part of the body or on different parts of the body. No more than one MRI scan will be performed in any 4-week period for this protocol....
Read the detailed description
Magnetic Resonance (MR) Imaging performed on volunteers will be used to develop and optimize techniques useful in the advancement of MRI technology.
- Conditions
- Cardiac Risk Factors, Healthy, Healthy Volunteers
- Keywords
- Healthy Volunteer, Magnetic Resonance Imaging, Gadolinium, Natural History, 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 |
|---|---|---|
| Volunteers | Volunteers (maybe Volunteers, NIH employee and current NIH protocol participants) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To refine current methodology and develop new techniques for MRI
To refine current methodology and develop new techniques for magnetic resonance imaging in the general population.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study start5 Jun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac Risk FactorsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bernadette A Redd, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130545
- Sponsor's protocol ID
- 100115
- Other IDs
- 10-CC-0115
- Status last verified
- 17 Sep 2026
- First submitted
- 25 May 2010
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are working on deciding if we want to share IPD.
Publications
Mattay 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 7862963Perez-Rodriguez J, Lai S, Ehst BD, Fine DM, Bluemke DA. Nephrogenic systemic fibrosis: incidence, associations, and effect of risk factor assessment--report of 33 cases. Radiology. 2009 Feb;250(2):371-7. doi: 10.1148/radiol.2502080498.
PubMed 19188312Frank 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 7928216Ahlman MA, Raman FS, Penzak SR, Pang J, Fan Z, Liu S, Gai N, Li D, Bluemke DA. Part 1 - Coronary angiography with gadofosveset trisodium: a prospective feasibility study evaluating injection techniques for steady-state imaging. BMC Cardiovasc Disord. 2015 Dec 22;15:177. doi: 10.1186/s12872-015-0176-0.
PubMed 26695065Raman FS, Nacif MS, Cater G, Gai N, Jones J, Li D, Sibley CT, Liu S, Bluemke DA. 3.0-T whole-heart coronary magnetic resonance angiography: comparison of gadobenate dimeglumine and gadofosveset trisodium. Int J Cardiovasc Imaging. 2013 Jun;29(5):1085-94. doi: 10.1007/s10554-013-0192-z. Epub 2013 Mar 21.
PubMed 23515949
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Techniques in MRI
- ClinicalTrials.gov ID
- NCT01130545
- Acronym / sponsor ID
- 100115
- Conditions
- Cardiac Risk Factors, Healthy, Healthy Volunteers
- Keywords
- Healthy Volunteer, Magnetic Resonance Imaging, Gadolinium, Natural History, HV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 5 Jun 2010 (actual)
- First posted
- 26 May 2010 (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.
Background:
- Magnetic resonance imaging (MRI) scans must be performed according to specified sets of parameters that provide optimal images of each organ and each area of the body. These scanning parameters are often specific to the institution or organization at which they are employed, and may also depend on the manufacturer of the MRI scanning equipment. Because MRI scanning equipment is always being updated and upgraded, researchers are interested in developing new and optimized scanning parameters for MRI scans.
Objectives:
- To improve current methods and develop new techniques for magnetic resonance imaging.
Eligibility:
- Individuals 18 years of age and older who are either volunteers or current NIH protocol participants.
- Participants must not have any medical history factors (e.g., extreme claustrophobia, history of metal implants) that would prevent them from receiving MRI scans.
Design:
- Participants will have at least one MRI scan that will last from 20 minutes to 2 hours (most scans will last between 45 and 90 minutes). The total time commitment for most visits will be approximately 4 hours from start to finish.
- Some MRI techniques require standard monitoring equipment or specific procedures during the scanning, such as an electrocardiogram.
- Participants will have blood samples taken at the time of the scan. Some MRI studies will require the use of a contrast agent that will be administered during the scan.
- Volunteers may be asked to return for additional MRI scans over the course of a few years. Follow-up scans may be done on the same part of the body or on different parts of the body. No more than one MRI scan will be performed in any 4-week period for this protocol....
Detailed description
Magnetic Resonance (MR) Imaging performed on volunteers will be used to develop and optimize techniques useful in the advancement of MRI technology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | –Volunteers (maybe Volunteers, NIH employee and current NIH protocol participants) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers (maybe Volunteers, NIH employee and current NIH protocol participants)
Key inclusion criteria (9 listed)
- Volunteer individuals
- Lab Eligibility parameters (for contrast scans within 4 weeks of gadolinium injection):
- Creatinine below upper normal limit
- eGFR >= 60 mL/min/1.73m2
- Age >= 60 or history of renal disease: test GFR within 1 week prior to contrast
Key exclusion criteria (21 listed)
- Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples:
- Aneurysm clip, implanted neural stimulator,
- Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices,
- Cochlear implant, ocular foreign body (metal shavings),
- Any implanted device (pumps, infusion devices, etc.),
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 refine current methodology and develop new techniques for MRI
Time frame: End of study
To refine current methodology and develop new techniques for magnetic resonance imaging in the general population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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 19188312Perez-Rodriguez J, Lai S, Ehst BD, Fine DM, Bluemke DA. Nephrogenic systemic fibrosis: incidence, associations, and effect of risk factor assessment--report of 33 cases. Radiology. 2009 Feb;250(2):371-7. doi: 10.1148/radiol.2502080498.
- 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.
- Derived from this study: PubMed 26695065Ahlman MA, Raman FS, Penzak SR, Pang J, Fan Z, Liu S, Gai N, Li D, Bluemke DA. Part 1 - Coronary angiography with gadofosveset trisodium: a prospective feasibility study evaluating injection techniques for steady-state imaging. BMC Cardiovasc Disord. 2015 Dec 22;15:177. doi: 10.1186/s12872-015-0176-0.
- Derived from this study: PubMed 23515949Raman FS, Nacif MS, Cater G, Gai N, Jones J, Li D, Sibley CT, Liu S, Bluemke DA. 3.0-T whole-heart coronary magnetic resonance angiography: comparison of gadobenate dimeglumine and gadofosveset trisodium. Int J Cardiovasc Imaging. 2013 Jun;29(5):1085-94. doi: 10.1007/s10554-013-0192-z. Epub 2013 Mar 21.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We are working on deciding if we want to share IPD.
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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.
Bernadette A Redd, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
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 Cardiac Risk Factors and Healthy, run by National Institutes of Health Clinical Center (CC) 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 9 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy L Cropper, R.N. ((301) 402-6132, tcropper@cc.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To refine current methodology and develop new techniques for MRI (time frame: End 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 NCT01130545, which also lists 5 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 Oct 2026.