Obstructive Coronary Artery DiseaseNCT01853592
Gadofosveset Trisodium for Heart Imaging Studies
An observational study of Obstructive Coronary Artery Disease and Coronary Arteriosclerosis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Coronary Artery Disease, Coronary Arteriosclerosis, Coronary Artery Disease (CAD)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2013to 13 Dec 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and sign informed consent.
- Able to complete an MRI scan.
- Age 18-45 years old.
- eGFR greater than or equal to 60mL/min/1.73m(2) within 1 week prior to gadolinium injection.
- NIH employees may be involved and NIH requirements will be followed as laid out in NIH Policy Manual 2300-630-3 - Leave Policy for NIH Employees Participating in NIH Medical Research Studies.
- Willing to travel to the NIH for scheduled follow-up visits and scans as well as potential repeat scans in the event of sub-optimal scanning.
Who cannot join
- Individuals will be excluded from the study if they have:
- Contra-indications to undergoing a MRA
- Please review Radiology MRI section MRI safety questionnaire.
- MRI with contrast within the last 6 months (self-reported) outside of our protocol.
- Contra indications to receiving gadolinium-based contrast agent (specified here and on MRI safety questionnaire):
- Allergy to gadolinium-based contrast
Show all 32Show fewer
- Labs:
- Kidney and liver function above the upper limits of normal
- eGFR < 60ml/min/1.73m(2)
- Pregnancy test: positive
- Acute renal failure, renal transplantation, curent dialysis treatment or hepatorenal syndrome
- History of liver transplantation or severe liver disease
- Severe Asthma
- Hemoglobinopathies
- History of multiple myeloma
- History of significant allergic reaction to gadolinium-based contrast agents
- Evaluated to be at increased risk for Nephrogenic Systemic Fibrosis (NSF).
- Current written (or self-reported) record of:
- atrial fibrillation
- cardiac surgery
- cancer treatment
- other comorbid conditions that otherwise indicates the participant has renal function that may deteriorate between study procedures due to the participant s underlying medical condition or that would not allow the study subject to complete the protocol.
- Current written (or self-reported) record of active:
- Clinically diagnosed angina, heart failure, and/or clinically significant electrical conduction abnormality in the heart.
- Pregnancy or lactation
- Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial
- Paralyzed hemidiaphragm
- Over 400 lbs and/or a body circumference that prevents adequate MRI gantry insertion.
- Unable to lay flat in the scanner
- Claustrophobia otherwise requiring anesthesia or sedation to undergo MRI.
- Participant is not able to undergo intravenous line placement and/or refuse gadolinium contrast.
- Any other conditions that precludes safety for MRI per the researcher s evaluation.
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: A Pilot Dosing Study for Gadofosveset Trisodium (Ablavar) for Coronary Magnetic Resonance Angiography (MRA)
Background:
- Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Researchers are interested in finding contrast agents that can help show problems with the blood vessels around the heart. They want to test an agent called Gadofosveset Trisodium to see how it works in MRI scans.
Read more
Objectives:
- To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.
Eligibility:
- Healthy volunteers between 18 and 45 years of age.
Design:
- Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions.
- Participants will have an MRI scan after the screening visit. They will have a dose of the contrast scan before the study.
- Participants will return for one additional MRI scan within 1 to 2 months of each scan. Different doses of the contrast agent will be used for each scan.
- An additional blood sample will be collected within 1 week of the second MRI scan.
Read the detailed description
The purpose of this study is to determine if the diagnostic quality of contrast-enhanced coronary magnetic resonance angiography (MRA) is improved by using a higher versus a lower dose of a gadolinium-based contrast agent. We will compare two doses of an intravascular contrast agent (Gadofosveset, 0.03 and 0.06 mmol/kg) in this pilot dosing study. Healthy participants will be recruited who do not have a clinical indication for MR angiography but do have safety clearance for IV gadolinium contrast and MR scanning.
Subjects will be evaluated in order to determine if the signal to noise ratio (SNR) and contrast to noise ratio (CNR) of the coronary arteries is increased for the higher dose contrast agent. Parameters will be compared with paired t-testing for significance.
- Conditions
- Obstructive Coronary Artery Disease, Coronary Arteriosclerosis, Coronary Artery Disease (CAD)
- Keywords
- Gadolinium Contrast, Cardiac MRI, MRA, MRI, MRI Safety
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate 0.06 mmol/kg Gadofosveset trisodium compared to 0.03 mmol/kg Gadofosveset trisodium for the diagnostic quality of MRA of the coronary arteries, as measured by changes in signal to noise & contrast to noise ratios.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study start8 Mar 2013
- Primary completion11 Feb 2014
- Study completion13 Dec 2016
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 Obstructive Coronary Artery DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David A Bluemke, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853592
- Sponsor's protocol ID
- 130098
- Other IDs
- 13-CC-0098
- Status last verified
- 13 Dec 2016
- First submitted
- 2 May 2013
- Last updated
- 10 Sep 2018
- Results posted
- No
Publications
Rhee CM, Bhan I, Alexander EK, Brunelli SM. Association between iodinated contrast media exposure and incident hyperthyroidism and hypothyroidism. Arch Intern Med. 2012 Jan 23;172(2):153-9. doi: 10.1001/archinternmed.2011.677.
PubMed 22271121Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
PubMed 18046031Gerber TC, Carr JJ, Arai AE, Dixon RL, Ferrari VA, Gomes AS, Heller GV, McCollough CH, McNitt-Gray MF, Mettler FA, Mieres JH, Morin RL, Yester MV. Ionizing radiation in cardiac imaging: a science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation. 2009 Feb 24;119(7):1056-65. doi: 10.1161/CIRCULATIONAHA.108.191650. Epub 2009 Feb 2. No abstract available.
PubMed 19188512Ahlman MA, Raman FS, Pang J, Zemrak F, Sandfort V, Penzak SR, Fan Z, Liu S, Li D, Bluemke DA. Part 2 - Coronary angiography with gadofosveset trisodium: a prospective intra-subject comparison for dose optimization for 100 % efficiency imaging. BMC Cardiovasc Disord. 2016 Mar 22;16:58. doi: 10.1186/s12872-015-0152-8.
PubMed 27004532
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Dosing Study for Gadofosveset Trisodium (Ablavar) for Coronary Magnetic Resonance Angiography (MRA)
- ClinicalTrials.gov ID
- NCT01853592
- Acronym / sponsor ID
- 130098
- Conditions
- Obstructive Coronary Artery Disease, Coronary Arteriosclerosis, Coronary Artery Disease (CAD)
- Keywords
- Gadolinium Contrast, Cardiac MRI, MRA, MRI, MRI Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Mar 2013
- Primary completion
- 11 Feb 2014 (actual)
- Study completion
- 13 Dec 2016 (actual)
- First posted
- 15 May 2013 (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) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Researchers are interested in finding contrast agents that can help show problems with the blood vessels around the heart. They want to test an agent called Gadofosveset Trisodium to see how it works in MRI scans.
Objectives:
- To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.
Eligibility:
- Healthy volunteers between 18 and 45 years of age.
Design:
- Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions.
- Participants will have an MRI scan after the screening visit. They will have a dose of the contrast scan before the study.
- Participants will return for one additional MRI scan within 1 to 2 months of each scan. Different doses of the contrast agent will be used for each scan.
- An additional blood sample will be collected within 1 week of the second MRI scan.
Detailed description
The purpose of this study is to determine if the diagnostic quality of contrast-enhanced coronary magnetic resonance angiography (MRA) is improved by using a higher versus a lower dose of a gadolinium-based contrast agent. We will compare two doses of an intravascular contrast agent (Gadofosveset, 0.03 and 0.06 mmol/kg) in this pilot dosing study. Healthy participants will be recruited who do not have a clinical indication for MR angiography but do have safety clearance for IV gadolinium contrast and MR scanning.
Subjects will be evaluated in order to determine if the signal to noise ratio (SNR) and contrast to noise ratio (CNR) of the coronary arteries is increased for the higher dose contrast agent. Parameters will be compared with paired t-testing for significance.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to understand and sign informed consent.
- Able to complete an MRI scan.
- Age 18-45 years old.
- eGFR greater than or equal to 60mL/min/1.73m(2) within 1 week prior to gadolinium injection.
- NIH employees may be involved and NIH requirements will be followed as laid out in NIH Policy Manual 2300-630-3 - Leave Policy for NIH Employees Participating in NIH Medical Research Studies.
Key exclusion criteria (32 listed)
- Contra-indications to undergoing a MRA
- Please review Radiology MRI section MRI safety questionnaire.
- MRI with contrast within the last 6 months (self-reported) outside of our protocol.
- Contra indications to receiving gadolinium-based contrast agent (specified here and on MRI safety questionnaire):
- Allergy to gadolinium-based contrast
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 evaluate 0.06 mmol/kg Gadofosveset trisodium compared to 0.03 mmol/kg Gadofosveset trisodium for the diagnostic quality of MRA of the coronary arteries, as measured by changes in signal to noise & contrast to noise ratios.
Time frame: 18 months
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 10 Sep 2018.
- Background: PubMed 22271121Rhee CM, Bhan I, Alexander EK, Brunelli SM. Association between iodinated contrast media exposure and incident hyperthyroidism and hypothyroidism. Arch Intern Med. 2012 Jan 23;172(2):153-9. doi: 10.1001/archinternmed.2011.677.
- Background: PubMed 18046031Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.
- Background: PubMed 19188512Gerber TC, Carr JJ, Arai AE, Dixon RL, Ferrari VA, Gomes AS, Heller GV, McCollough CH, McNitt-Gray MF, Mettler FA, Mieres JH, Morin RL, Yester MV. Ionizing radiation in cardiac imaging: a science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation. 2009 Feb 24;119(7):1056-65. doi: 10.1161/CIRCULATIONAHA.108.191650. Epub 2009 Feb 2. No abstract available.
- Derived from this study: PubMed 27004532Ahlman MA, Raman FS, Pang J, Zemrak F, Sandfort V, Penzak SR, Fan Z, Liu S, Li D, Bluemke DA. Part 2 - Coronary angiography with gadofosveset trisodium: a prospective intra-subject comparison for dose optimization for 100 % efficiency imaging. BMC Cardiovasc Disord. 2016 Mar 22;16:58. doi: 10.1186/s12872-015-0152-8.
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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.
David A Bluemke, 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 Obstructive Coronary Artery Disease and Coronary Arteriosclerosis, 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 6 inclusion and 32 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 10 Sep 2018. 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.
What does the primary outcome measure?
To evaluate 0.06 mmol/kg Gadofosveset trisodium compared to 0.03 mmol/kg Gadofosveset trisodium for the diagnostic quality of MRA of the coronary arteries, as measured by changes in signal to noise & contrast to noise ratios. (time frame: 18 months). 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 NCT01853592, 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 10 Sep 2018.