Brain IschemiaNCT00015717
Magnetic Resonance Imaging to Investigate Silent Strokes During Neck and Skull Angioplasty
An observational study of Brain Ischemia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use magnetic resonance imaging (MRI) to determine if silent strokes occur during angioplasty of the blood vessels in the neck or skull. Neck and skull angioplasties are relatively new procedures whose possible complications are still under investigation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Ischemia
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Mar 2004
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men and women age 18 years or older admitted for angioplasty with or without stenting of any intra or extra-cranial vessel.
Who cannot join
- Any MRI contraindication (insulin pump, aneurysm clips, implanted neural stimulator, cardiac pacemaker or defibrillator, cochlear implant, metal shrapnel or bullet)
- Patients with hyperperfusion syndrome following the angioplasty.
- Patients with cardiovascular or respiratory instability.
- Patients with severe peri-procedural stroke at risk for herniation.
- Confused or encephalopathic patients who are unable to cooperate.
- Pregnant women.
- Lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Silent Cerebral Ischemia After Cervico-Cranial Angioplasty Detected by Diffusion-Weighted MRI
This study will use magnetic resonance imaging (MRI) to determine if silent strokes occur during angioplasty of the blood vessels in the neck or skull. Neck and skull angioplasties are relatively new procedures whose possible complications are still under investigation.
Patients 18 years of age or older who are admitted to Suburban Hospital in Bethesda, Maryland, for angioplasty of one or more of the blood vessels in the neck or skull may participate in this study. Participants must be able to undergo a brain MRI. Within 24 hours before their angioplasty, patients will provide a medical history and have a physical examination and brain MRI. The physical examination and MRI will be repeated within 24 hours after the angioplasty.
Read more
MRI is a diagnostic test that uses a magnetic field and radio waves to show structural and chemical changes in tissues. This technique is more sensitive than X-rays in detecting some changes that occur in diseases of the brain. For the procedure, the patient lies on a table that slides into a metal cylinder (the scanner). The confined space may produce anxiety in some patients, and patients can talk to the technician at all times during the procedure. Earplugs are provided to muffle loud knocking and pulsing noises that occur while the scanner is taking pictures. During the study, the contrast material gadolinium may be injected into an arm vein. Gadolinium "brightens" the pictures, producing better images of brain blood flow.
Patients will be contacted by telephone 30 days after the procedure to follow how they are doing and learn whether any complications resulted from the angioplasty.
Read the detailed description
Recently cervico-cranial angioplasty and stenting (CCAS) has been introduced as alternative treatment for occlusive disease of the extracranial and the intracranial vessels. Temporary or permanent clinically detectable neurological deficits occur in up to 13% of all patients undergoing CASS and are usually related to distal embolization or hemodynamic insufficiency. Silent cerebral micro-emboli are known to occur in patients undergoing carotid endarterectomy and angioplasty but are believed to be of little clinical significance. Distal embolization may be a technical concern when performing CCAS and could cause silent cerebral ischemia. High resolution diffusion-weighted MRI may detect silent hyperacute ischemic lesions in patients undergoing CCAS and examination by a stroke neurologist may detect clinical deficits otherwise unrecognized.
- Conditions
- Brain Ischemia
- Keywords
- Imaging, Complications, Stenosis, Treatment, Strokes, Cerebral Ischemia, Cranial Cervical Angioplasty
- Medical subject headings
- Brain Ischemia, Constriction, Pathologic, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2001 (estimated)
- Study startApr 2001
- Study completionMar 2004
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 Brain IschemiaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)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
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015717
- Sponsor's protocol ID
- 010146
- Other IDs
- 01-N-0146
- Status last verified
- Mar 2004
- First submitted
- 2 May 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Gil-Peralta A, Mayol A, Marcos JR, Gonzalez A, Ruano J, Boza F, Duran F. Percutaneous transluminal angioplasty of the symptomatic atherosclerotic carotid arteries. Results, complications, and follow-up. Stroke. 1996 Dec;27(12):2271-3. doi: 10.1161/01.str.27.12.2271.
PubMed 8969792Qureshi AI, Luft AR, Janardhan V, Suri MF, Sharma M, Lanzino G, Wakhloo AK, Guterman LR, Hopkins LN. Identification of patients at risk for periprocedural neurological deficits associated with carotid angioplasty and stenting. Stroke. 2000 Feb;31(2):376-82. doi: 10.1161/01.str.31.2.376.
PubMed 10657409Lovblad KO, Pluschke W, Remonda L, Gruber-Wiest D, Do DD, Barth A, Kniemeyer HW, Bassetti C, Mattle HP, Schroth G. Diffusion-weighted MRI for monitoring neurovascular interventions. Neuroradiology. 2000 Feb;42(2):134-8. doi: 10.1007/s002340050032.
PubMed 10663492
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
- Silent Cerebral Ischemia After Cervico-Cranial Angioplasty Detected by Diffusion-Weighted MRI
- ClinicalTrials.gov ID
- NCT00015717
- Acronym / sponsor ID
- 010146
- Conditions
- Brain Ischemia
- Keywords
- Imaging, Complications, Stenosis, Treatment, Strokes, Cerebral Ischemia, Cranial Cervical Angioplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Apr 2001
- Study completion
- Mar 2004
- First posted
- 3 May 2001 (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 use magnetic resonance imaging (MRI) to determine if silent strokes occur during angioplasty of the blood vessels in the neck or skull. Neck and skull angioplasties are relatively new procedures whose possible complications are still under investigation.
Patients 18 years of age or older who are admitted to Suburban Hospital in Bethesda, Maryland, for angioplasty of one or more of the blood vessels in the neck or skull may participate in this study. Participants must be able to undergo a brain MRI. Within 24 hours before their angioplasty, patients will provide a medical history and have a physical examination and brain MRI. The physical examination and MRI will be repeated within 24 hours after the angioplasty.
MRI is a diagnostic test that uses a magnetic field and radio waves to show structural and chemical changes in tissues. This technique is more sensitive than X-rays in detecting some changes that occur in diseases of the brain. For the procedure, the patient lies on a table that slides into a metal cylinder (the scanner). The confined space may produce anxiety in some patients, and patients can talk to the technician at all times during the procedure. Earplugs are provided to muffle loud knocking and pulsing noises that occur while the scanner is taking pictures. During the study, the contrast material gadolinium may be injected into an arm vein. Gadolinium "brightens" the pictures, producing better images of brain blood flow.
Patients will be contacted by telephone 30 days after the procedure to follow how they are doing and learn whether any complications resulted from the angioplasty.
Detailed description
Recently cervico-cranial angioplasty and stenting (CCAS) has been introduced as alternative treatment for occlusive disease of the extracranial and the intracranial vessels. Temporary or permanent clinically detectable neurological deficits occur in up to 13% of all patients undergoing CASS and are usually related to distal embolization or hemodynamic insufficiency. Silent cerebral micro-emboli are known to occur in patients undergoing carotid endarterectomy and angioplasty but are believed to be of little clinical significance. Distal embolization may be a technical concern when performing CCAS and could cause silent cerebral ischemia. High resolution diffusion-weighted MRI may detect silent hyperacute ischemic lesions in patients undergoing CCAS and examination by a stroke neurologist may detect clinical deficits otherwise unrecognized.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women age 18 years or older admitted for angioplasty with or without stenting of any intra or extra-cranial vessel.
Key exclusion criteria (7 listed)
- Any MRI contraindication (insulin pump, aneurysm clips, implanted neural stimulator, cardiac pacemaker or defibrillator, cochlear implant, metal shrapnel or bullet)
- Patients with hyperperfusion syndrome following the angioplasty.
- Patients with cardiovascular or respiratory instability.
- Patients with severe peri-procedural stroke at risk for herniation.
- Confused or encephalopathic patients who are unable to cooperate.
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
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 8969792Gil-Peralta A, Mayol A, Marcos JR, Gonzalez A, Ruano J, Boza F, Duran F. Percutaneous transluminal angioplasty of the symptomatic atherosclerotic carotid arteries. Results, complications, and follow-up. Stroke. 1996 Dec;27(12):2271-3. doi: 10.1161/01.str.27.12.2271.
- Background: PubMed 10657409Qureshi AI, Luft AR, Janardhan V, Suri MF, Sharma M, Lanzino G, Wakhloo AK, Guterman LR, Hopkins LN. Identification of patients at risk for periprocedural neurological deficits associated with carotid angioplasty and stenting. Stroke. 2000 Feb;31(2):376-82. doi: 10.1161/01.str.31.2.376.
- Background: PubMed 10663492Lovblad KO, Pluschke W, Remonda L, Gruber-Wiest D, Do DD, Barth A, Kniemeyer HW, Bassetti C, Mattle HP, Schroth G. Diffusion-weighted MRI for monitoring neurovascular interventions. Neuroradiology. 2000 Feb;42(2):134-8. doi: 10.1007/s002340050032.
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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?
An observational study of Brain Ischemia, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 7 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.
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 NCT00015717, 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.