ArteriosclerosisPhase 1NCT00029575
Magnetic Resonance Imaging of Narrowed Arteries
A Phase 1 study testing Surgi-Vision Guidewire Coil in people with Arteriosclerosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will compare four methods of imaging arteries: angiography (x-ray picture) intravascular ultrasound (ultrasound from inside the artery) magnetic resonance imaging (MRI) from outside the body MRI using an antenna to take pictures inside the arteries of the pelvis Standard angiography shows blockages inside… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arteriosclerosis
- What is being tested?
- Surgi-Vision Guidewire Coil
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Dec 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients undergoing a clinically driven transfemoral diagnostic or therapeutic cardiac or peripheral catheterization procedure
Who cannot join
- Contraindication to Heparin
- Patients less than 21 years old
- Pregnant or lactating women
- Prior allergic reaction to Gadolinium contrast
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
Show all 13Show fewer
- Neural stimulator (e.g. TENS-Unit)
- Any type of ear implant
- Metal in eye (e.g. from machining)
- Any implanted device (e.g. insulin pump, drug infusion device)
- EXCLUSION CRITERIA - Contraindications to Iodinated Contrast in a Research Study:
- Serum creatinine greater than 2.0 mg/dl
- Decompensated congestive heart failure
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Intravascular Narrow Field Magnetic Resonance Arterial Wall Imaging
This study will compare four methods of imaging arteries:
- angiography (x-ray picture)
- intravascular ultrasound (ultrasound from inside the artery)
- magnetic resonance imaging (MRI) from outside the body
- MRI using an antenna to take pictures inside the arteries of the pelvis
Read more
Standard angiography shows blockages inside the artery, but does not provide any information about the arterial wall itself. New ways of looking at the artery walls with MRI and ultrasound may provide insight into how arteries cause disease.
Patients 21 years of age and older who require catheterization and angiography of the heart, kidney, or leg arteries because of atherosclerosis (narrowing of the arteries), may be eligible for this study. Participants will undergo MRI and intravascular ultrasound of the arteries immediately after their catheterization and angiography. The additional imaging will add from 1 to 2 hours to the angiogram procedure.
- Angiography: Using the sheaths already in place in the groin artery, catheters (flexible plastic tubes) are placed inside the arteries in order to inject a contrast dye to take x-ray pictures. (Patients who had an angiogram of the leg artery as part of their medical care will not repeat this test.)
- Intravascular ultrasound: An anti-clotting drug called heparin is given through a vein to prevent clot formation. Blood samples are taken during the test to see if more heparin is needed. Special wires are used to guide the catheters to the proper location inside the arteries. A special ultrasound catheter is advanced over one of these wires to the large artery that supplies blood to the legs. X-rays are used to help the physician place the ultrasound in the correct location to take ultrasound pictures of the artery wall.
- Magnetic resonance imaging: A special MRI catheter is advanced through the catheter in the groin. With the catheter in place, the patient is carried to a stretcher and moved into a long metal cylinder (the MRI scanner) for imaging. During the scanning, a contrast drug called gadolinium is injected into an arm vein to brighten the images. The patient is able to speak through a microphone at all times to the person taking the pictures.
Read the detailed description
Coronary artery disease remains the leading cause of death in the United States. Disruption of atherosclerotic plaque is associated with acute coronary syndromes including myocardial infarction, but culprit lesions are difficult to identify beforehand. Animal models of atherosclerosis have proven limited. In vivo plaque characterization might be useful both in plaque prognostication and in understanding human vascular biology. One imaging modality, high-resolution magnetic resonance imaging (MRI), has been shown feasible for plaque visualization and characterization, but still has important limitations. In this pilot study we hope to apply a new MRI modality using coils (antennae) that are inside the artery being studied, to achieve superior imaging.
This pilot study will examine whether intravascular arterial wall MRI can visualize the arterial wall with a higher spatial resolution than currently available techniques of intravascular ultrasound or conventional magnetic resonance imaging using surface receiver coils. In particular, we hope to image in high resolution, for the first time, the outer arterial wall (adventitia), which is not readily visualized. MRI using intravascular coils may also enable the study of blood flow and contrast accumulation within arterial walls, potentially key markers of plaque angiogenesis and vulnerability.
- Conditions
- Arteriosclerosis
- Being tested
- Surgi-Vision Guidewire Coil
- Keywords
- Atherosclerotic, Plaque, Resolution, Adventitia, Ultrasound, Cardiac Catheterization, Arteriosclerosis, Coronary Artery Disease
- Medical subject headings
- Arteriosclerosis, Plaque, Amyloid, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgi-Vision Guidewire CoilDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2002 (estimated)
- Study startJan 2002
- Study completionDec 2003
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 ArteriosclerosisStudies 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
- 25 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029575
- Sponsor's protocol ID
- 020071
- Other IDs
- 02-H-0071
- Status last verified
- Dec 2003
- First submitted
- 15 Jan 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Barker SG, Tilling LC, Miller GC, Beesley JE, Fleetwood G, Stavri GT, Baskerville PA, Martin JF. The adventitia and atherogenesis: removal initiates intimal proliferation in the rabbit which regresses on generation of a 'neoadventitia'. Atherosclerosis. 1994 Feb;105(2):131-44. doi: 10.1016/0021-9150(94)90043-4.
PubMed 8003089Scott NA, Cipolla GD, Ross CE, Dunn B, Martin FH, Simonet L, Wilcox JN. Identification of a potential role for the adventitia in vascular lesion formation after balloon overstretch injury of porcine coronary arteries. Circulation. 1996 Jun 15;93(12):2178-87. doi: 10.1161/01.cir.93.12.2178.
PubMed 8925587Shi Y, O'Brien JE, Fard A, Mannion JD, Wang D, Zalewski A. Adventitial myofibroblasts contribute to neointimal formation in injured porcine coronary arteries. Circulation. 1996 Oct 1;94(7):1655-64. doi: 10.1161/01.cir.94.7.1655.
PubMed 8840858
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Narrow Field Magnetic Resonance Arterial Wall Imaging
- ClinicalTrials.gov ID
- NCT00029575
- Acronym / sponsor ID
- 020071
- Conditions
- Arteriosclerosis
- Keywords
- Atherosclerotic, Plaque, Resolution, Adventitia, Ultrasound, Cardiac Catheterization, Arteriosclerosis, Coronary Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 2002
- Study completion
- Dec 2003
- First posted
- 16 Jan 2002 (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 compare four methods of imaging arteries:
- angiography (x-ray picture)
- intravascular ultrasound (ultrasound from inside the artery)
- magnetic resonance imaging (MRI) from outside the body
- MRI using an antenna to take pictures inside the arteries of the pelvis
Standard angiography shows blockages inside the artery, but does not provide any information about the arterial wall itself. New ways of looking at the artery walls with MRI and ultrasound may provide insight into how arteries cause disease.
Patients 21 years of age and older who require catheterization and angiography of the heart, kidney, or leg arteries because of atherosclerosis (narrowing of the arteries), may be eligible for this study. Participants will undergo MRI and intravascular ultrasound of the arteries immediately after their catheterization and angiography. The additional imaging will add from 1 to 2 hours to the angiogram procedure.
- Angiography: Using the sheaths already in place in the groin artery, catheters (flexible plastic tubes) are placed inside the arteries in order to inject a contrast dye to take x-ray pictures. (Patients who had an angiogram of the leg artery as part of their medical care will not repeat this test.)
- Intravascular ultrasound: An anti-clotting drug called heparin is given through a vein to prevent clot formation. Blood samples are taken during the test to see if more heparin is needed. Special wires are used to guide the catheters to the proper location inside the arteries. A special ultrasound catheter is advanced over one of these wires to the large artery that supplies blood to the legs. X-rays are used to help the physician place the ultrasound in the correct location to take ultrasound pictures of the artery wall.
- Magnetic resonance imaging: A special MRI catheter is advanced through the catheter in the groin. With the catheter in place, the patient is carried to a stretcher and moved into a long metal cylinder (the MRI scanner) for imaging. During the scanning, a contrast drug called gadolinium is injected into an arm vein to brighten the images. The patient is able to speak through a microphone at all times to the person taking the pictures.
Detailed description
Coronary artery disease remains the leading cause of death in the United States. Disruption of atherosclerotic plaque is associated with acute coronary syndromes including myocardial infarction, but culprit lesions are difficult to identify beforehand. Animal models of atherosclerosis have proven limited. In vivo plaque characterization might be useful both in plaque prognostication and in understanding human vascular biology. One imaging modality, high-resolution magnetic resonance imaging (MRI), has been shown feasible for plaque visualization and characterization, but still has important limitations. In this pilot study we hope to apply a new MRI modality using coils (antennae) that are inside the artery being studied, to achieve superior imaging.
This pilot study will examine whether intravascular arterial wall MRI can visualize the arterial wall with a higher spatial resolution than currently available techniques of intravascular ultrasound or conventional magnetic resonance imaging using surface receiver coils. In particular, we hope to image in high resolution, for the first time, the outer arterial wall (adventitia), which is not readily visualized. MRI using intravascular coils may also enable the study of blood flow and contrast accumulation within arterial walls, potentially key markers of plaque angiogenesis and vulnerability.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing a clinically driven transfemoral diagnostic or therapeutic cardiac or peripheral catheterization procedure
Key exclusion criteria (13 listed)
- Contraindication to Heparin
- Patients less than 21 years old
- Pregnant or lactating women
- Prior allergic reaction to Gadolinium contrast
- Cardiac pacemaker or implantable defibrillator
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 |
|---|---|---|
| Surgi-Vision Guidewire Coil | Device | – |
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 4 Mar 2008.
- Background: PubMed 8003089Barker SG, Tilling LC, Miller GC, Beesley JE, Fleetwood G, Stavri GT, Baskerville PA, Martin JF. The adventitia and atherogenesis: removal initiates intimal proliferation in the rabbit which regresses on generation of a 'neoadventitia'. Atherosclerosis. 1994 Feb;105(2):131-44. doi: 10.1016/0021-9150(94)90043-4.
- Background: PubMed 8925587Scott NA, Cipolla GD, Ross CE, Dunn B, Martin FH, Simonet L, Wilcox JN. Identification of a potential role for the adventitia in vascular lesion formation after balloon overstretch injury of porcine coronary arteries. Circulation. 1996 Jun 15;93(12):2178-87. doi: 10.1161/01.cir.93.12.2178.
- Background: PubMed 8840858Shi Y, O'Brien JE, Fard A, Mannion JD, Wang D, Zalewski A. Adventitial myofibroblasts contribute to neointimal formation in injured porcine coronary arteries. Circulation. 1996 Oct 1;94(7):1655-64. doi: 10.1161/01.cir.94.7.1655.
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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?
A Phase 1 study testing Surgi-Vision Guidewire Coil in people with Arteriosclerosis, 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 13 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 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029575, 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 4 Mar 2008.