Peripheral Artery DiseasePhase 1NCT00064896
Technical Development of Cardiovascular Magnetic Resonance Imaging
A Phase 1 study testing MRI in people with Peripheral Artery Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
The goal of this study is to develop advances in cardiovascular diagnostic and treatment methods using magnetic resonance imaging (MRI), a test that uses a strong magnetic field and radio waves to show anatomic detail. For the scan, the patient lies on a table in a cylinder containing a magnetic field. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2003to 26 Oct 2017
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with known or suspected cardiovascular disease will be eligible for participation in this protocol. The subject is eligible under the following conditions:
- Subject's age is greater than 18 years of age.
- Expected to undergo, or having undergone, a clinically-indicated diagnostic or therapeutic catheterization procedure or MRI angiogram procedure.
- Additional Inclusion Criteria for Section #4: Magnetic Resonance Imaging of Peripheral Arterial Atherosclerosis
- -Known or suspected peripheral artery occlusion.
Who cannot join
- Subjects with absolute contraindications to MRI scanning will be excluded. These contraindications include subjects with the following devices:
- Implanted cardiac pacemaker or defibrillator
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
Show all 19Show fewer
- Insulin pump
- Metal shrapnel or bullet.
- When subjects can provide evidence that their implanted device is labeled compatible with MRI, exceptions to the above exclusions can be made and recorded in the note. Furthermore, the FOLLOWING SUBJECT GROUPS WILL BE EXCLUDED because of the administration of MRI CONTRAST AGENTS:
- Pregnant women (Subjects who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test) or Lactating Women.
- Subjects with hemoglobinopathies
- Subjects with renal disease (eGFR[R] less than 30 mL/min/1.73m(2))
- Glomerular filtration rate will be estimated using the MDRD 2005 revised study formula:
- eGFR (mL/min/1.73m (2)) equal 175 x (standardized Scr) (-1.154) x (age) (-0.203) x 0.742 (if the subject is female) or x 1.212 (if the subject is black)
- However, if the eGFR less than 30 mL/min/1.73m(2) and gadolinium contrast exposure is thought likely to reduce the overall risk of the medically necessary interventional procedure in Specific Aim number 2, then with informed consent and the concurrence of the attending physician, the patient may be enrolled in the study. This would be documented in the medical record, and the IRB would be notified.
- Additional Exclusion Criteria for Section #2: Lower Extremity Perfusion Measures
- A patent autologous or prosthetic bypass graft that would require compression during arterial occlusion to induce reactive hyperemia. This exclusion is intended to avoid graft injury and possible thrombosis. If an old graft is known to be non-functional, from radiocontrast or MRI angiography, then this exclusion does not apply.
- A patent intravascular stent in a territory that would be compressed during arterial occlusion to induce reactive hyperemia. This exclusion is intended to avoid theoretical stent crush or fracture. If the stented vessel is known to be completely occluded, from radiocontrast or MRI angiography, then this exclusion does not apply. However, occlusive cuffs may be placed above or below stent devices to avoid this theoretical complication.
- Active deep vein thrombosis of the lower extremity based on clinical findings.
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
The goal of this study is to develop advances in cardiovascular diagnostic and treatment methods using magnetic resonance imaging (MRI), a test that uses a strong magnetic field and radio waves to show anatomic detail. For the scan, the patient lies on a table in a cylinder containing a magnetic field. He or she can communicate with a staff member at all times during the procedure.
Patients 18 years of age or older who require 1) catheterization of the leg arteries for diagnosis or treatment of blocked arteries, or 2) heart catheterization for diagnosis or treatment of coronary artery disease or other heart problems may be eligible for this study. Participants will undergo one of the following procedures:
Read more
Blood Flow Measurement Using Standard Techniques and MRI
For patients with blockage in a leg artery, blood flow will be measured before and after successful catheter-based treatment (angioplasty or stenting) using standard venous occlusion plethysmography and a newer MRI technique. (Patients whose treatment is not successful will not undergo follow-up blood flow measurements in this study.) For venous occlusion plethysmography, a large pressure cuff is placed around the upper or lower legs. Thin elastic bands called a strain gauge are placed around the calves to measure blood blow to the legs. The pressure cuffs are inflated for 5 minutes, preventing blood from flowing to the legs, and are then deflated, allowing the blood to rush to the legs. A smaller cuff is inflated to a low pressure, and the strain gauge measures this maximum blood flow to the legs for 1 or 2 more minutes. For the new MRI technique, blood flow is measured while the patient is in the MRI scanner. Flow is first measured with the patient at rest. Then, the large pressure cuff is inflated for 5 minutes. The cuff is deflated and additional images are taken. Before the cuff is deflated, a dye called gadolinium contrast is injected into an arm vein to brighten the images. Patients may undergo six to eight cuff inflations on four to six different days.
Fusion of X-Ray and MRI Images of Peripheral Arteries
For patients with blockage in a leg artery Participants will undergo catheterization and MRI of the legs. Special plastic beads are taped to the leg(s) to help compare the MRI and x-ray pictures. For the catheterization procedure, x-rays of the blood vessels are taken to guide placement of the catheters. Contrast dye is injected to brighten the images of the blood vessels. These injections work well in normal and partly blocked arteries, but not in arteries that are completely blocked. For this study, patients first have an MRI scan of their legs. During the scan, gadolinium contrast dye is injected into an arm vein. Then, during the catheterization procedure, a computer aligns the MRI pictures with the x-ray pictures to see if the combined images allow the doctor to better see where to place the catheters.
Fusion of X-ray and MRI Images of the Heart
For patients undergoing heart catheterization will undergo MRI and heart catheterization. Special plastic beads are taped to the chest to help compare the MRI and x-ray pictures. Patients first have an MRI scan of their heart. During the scan, gadolinium contrast dye is injected into an arm vein. Then, during the catheterization procedure, a computer aligns the MRI pictures with the x-ray pictures to see if the combined images allow the doctor to learn more about the pattern of heart disease.
Heart rhythm, blood pressure, heart function, and breathing will be monitored during all the MRIs.
Read the detailed description
Cardiovascular interventional procedures are minimally-invasive, catheter-based treatments such as coronary artery angioplasty and stenting. These procedures generally can be conducted on awake patients with few complications, and were developed as alternatives to conventional open surgery. Conventional cardiovascular interventional procedures are conducted by physicians manipulating medical devices inside patients under the guidance of fluoroscopic x-ray.
We are developing minimally-invasive cardiovascular interventional procedures using real-time magnetic resonance imaging, also known as MR Fluoroscopy. These procedures have the advantage of excellent imaging without surgery and without radiation exposure or toxic contrast agents (dyes). Moreover, because MR Fluoroscopy can produce excellent images of soft tissue, blood, and of three-dimensional structures, it may be possible to guide minimally-invasive procedures not possible even with invasive surgery.
The goal of this protocol is to develop and test incremental technical advances in patients.
- Conditions
- Peripheral Artery Disease
- Being tested
- MRI
- Keywords
- Blood Flow, Revascularization, Image Fusion, Fluoroscopy, MRI, Chronic Total Occlusion of Arteries, Claudication, Safety, Atherosclerosis, Cardiovascular Disease
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop, test, and provide adjunctive information to the operator derived from MRI during the management of patients being considered for, or undergoing, invasive procedures.
Secondary outcomes (1)
This protocol aims to develop and test novel MRI techniques in patients being treated for cardiovascular disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2003 (estimated)
- Study start14 Jul 2003
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064896
- Sponsor's protocol ID
- 030250
- Other IDs
- 03-H-0250
- Status last verified
- 26 Oct 2017
- First submitted
- 14 Jul 2003
- Last updated
- 30 Oct 2017
- Results posted
- No
Publications
Murphy KP, Szopinski KT, Cohan RH, Mermillod B, Ellis JH. Occurrence of adverse reactions to gadolinium-based contrast material and management of patients at increased risk: a survey of the American Society of Neuroradiology Fellowship Directors. Acad Radiol. 1999 Nov;6(11):656-64. doi: 10.1016/S1076-6332(99)80114-7.
PubMed 10894068
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00064896
- Acronym / sponsor ID
- 030250
- Conditions
- Peripheral Artery Disease
- Keywords
- Blood Flow, Revascularization, Image Fusion, Fluoroscopy, MRI, Chronic Total Occlusion of Arteries, Claudication, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 14 Jul 2003
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 15 Jul 2003 (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.
The goal of this study is to develop advances in cardiovascular diagnostic and treatment methods using magnetic resonance imaging (MRI), a test that uses a strong magnetic field and radio waves to show anatomic detail. For the scan, the patient lies on a table in a cylinder containing a magnetic field. He or she can communicate with a staff member at all times during the procedure.
Patients 18 years of age or older who require 1) catheterization of the leg arteries for diagnosis or treatment of blocked arteries, or 2) heart catheterization for diagnosis or treatment of coronary artery disease or other heart problems may be eligible for this study. Participants will undergo one of the following procedures:
Blood Flow Measurement Using Standard Techniques and MRI
For patients with blockage in a leg artery, blood flow will be measured before and after successful catheter-based treatment (angioplasty or stenting) using standard venous occlusion plethysmography and a newer MRI technique. (Patients whose treatment is not successful will not undergo follow-up blood flow measurements in this study.) For venous occlusion plethysmography, a large pressure cuff is placed around the upper or lower legs. Thin elastic bands called a strain gauge are placed around the calves to measure blood blow to the legs. The pressure cuffs are inflated for 5 minutes, preventing blood from flowing to the legs, and are then deflated, allowing the blood to rush to the legs. A smaller cuff is inflated to a low pressure, and the strain gauge measures this maximum blood flow to the legs for 1 or 2 more minutes. For the new MRI technique, blood flow is measured while the patient is in the MRI scanner. Flow is first measured with the patient at rest. Then, the large pressure cuff is inflated for 5 minutes. The cuff is deflated and additional images are taken. Before the cuff is deflated, a dye called gadolinium contrast is injected into an arm vein to brighten the images. Patients may undergo six to eight cuff inflations on four to six different days.
Fusion of X-Ray and MRI Images of Peripheral Arteries
For patients with blockage in a leg artery Participants will undergo catheterization and MRI of the legs. Special plastic beads are taped to the leg(s) to help compare the MRI and x-ray pictures. For the catheterization procedure, x-rays of the blood vessels are taken to guide placement of the catheters. Contrast dye is injected to brighten the images of the blood vessels. These injections work well in normal and partly blocked arteries, but not in arteries that are completely blocked. For this study, patients first have an MRI scan of their legs. During the scan, gadolinium contrast dye is injected into an arm vein. Then, during the catheterization procedure, a computer aligns the MRI pictures with the x-ray pictures to see if the combined images allow the doctor to better see where to place the catheters.
Fusion of X-ray and MRI Images of the Heart
For patients undergoing heart catheterization will undergo MRI and heart catheterization. Special plastic beads are taped to the chest to help compare the MRI and x-ray pictures. Patients first have an MRI scan of their heart. During the scan, gadolinium contrast dye is injected into an arm vein. Then, during the catheterization procedure, a computer aligns the MRI pictures with the x-ray pictures to see if the combined images allow the doctor to learn more about the pattern of heart disease.
Heart rhythm, blood pressure, heart function, and breathing will be monitored during all the MRIs.
Detailed description
Cardiovascular interventional procedures are minimally-invasive, catheter-based treatments such as coronary artery angioplasty and stenting. These procedures generally can be conducted on awake patients with few complications, and were developed as alternatives to conventional open surgery. Conventional cardiovascular interventional procedures are conducted by physicians manipulating medical devices inside patients under the guidance of fluoroscopic x-ray.
We are developing minimally-invasive cardiovascular interventional procedures using real-time magnetic resonance imaging, also known as MR Fluoroscopy. These procedures have the advantage of excellent imaging without surgery and without radiation exposure or toxic contrast agents (dyes). Moreover, because MR Fluoroscopy can produce excellent images of soft tissue, blood, and of three-dimensional structures, it may be possible to guide minimally-invasive procedures not possible even with invasive surgery.
The goal of this protocol is to develop and test incremental technical advances in patients.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with known or suspected cardiovascular disease will be eligible for participation in this protocol. The subject is eligible under the following conditions:
- Subject's age is greater than 18 years of age.
- Expected to undergo, or having undergone, a clinically-indicated diagnostic or therapeutic catheterization procedure or MRI angiogram procedure.
- Additional Inclusion Criteria for Section #4: Magnetic Resonance Imaging of Peripheral Arterial Atherosclerosis
- -Known or suspected peripheral artery occlusion.
Key exclusion criteria (19 listed)
- Subjects with absolute contraindications to MRI scanning will be excluded. These contraindications include subjects with the following devices:
- Implanted cardiac pacemaker or defibrillator
- Central nervous system aneurysm clips
- Implanted neural stimulator
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI | Procedure or surgery | – |
Primary outcome
To develop, test, and provide adjunctive information to the operator derived from MRI during the management of patients being considered for, or undergoing, invasive procedures.
1 secondary outcome
This protocol aims to develop and test novel MRI techniques in patients being treated for cardiovascular disease.
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 30 Oct 2017.
- Background: PubMed 10894068Murphy KP, Szopinski KT, Cohan RH, Mermillod B, Ellis JH. Occurrence of adverse reactions to gadolinium-based contrast material and management of patients at increased risk: a survey of the American Society of Neuroradiology Fellowship Directors. Acad Radiol. 1999 Nov;6(11):656-64. doi: 10.1016/S1076-6332(99)80114-7.
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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?
A Phase 1 study testing MRI in people with Peripheral Artery Disease, 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 5 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 30 Oct 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 develop, test, and provide adjunctive information to the operator derived from MRI during the management of patients being considered for, or undergoing, invasive procedures.. 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 NCT00064896, which also lists 1 linked publication.
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 30 Oct 2017.