CLINICAL TRIAL

Ferumoxytol Injectable Product for Cerebral Atherosclerosis

EnrollingByInvitation · 18+ · All Sexes · New Haven, CT

This study is evaluating whether high-resolution MRI can be used to detect intracranial atherosclerosis and intracranial aneurysms.

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About the trial for Cerebral Atherosclerosis

Eligible Conditions
Intracranial Aneurysm · Aneurysm · Atherosclerosis · Intracranial Atherosclerosis · Stroke · Intracranial Arteriosclerosis

Treatment Groups

This trial involves 2 different treatments. Ferumoxytol Injectable Product is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Ferumoxytol Injectable Product
DRUG
Experimental Group 2
Ferumoxytol Injectable Product
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cerebral Atherosclerosis or one of the other 5 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The study will compare patients with intracranial atherosclerosis to those with intracranial aneurysms show original
- age 18 to 80 years - first ever stroke A recent ischemic stroke within the last 14 days show original
10 asymptomatic
Patients who have had a recent rupture of an intracranial aneurysm are at risk for developing a second aneurysm. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ferumoxytol Injectable Product will improve 2 primary outcomes in patients with Cerebral Atherosclerosis. Measurement will happen over the course of 4 days.

Vessel Wall Enhancement with Gadolinium compared to Vessel Wall Enhancement with Ferumoxytol in intracranial aneurysm (IA) group
4 DAYS
Both patient groups will have a high-resolution vessel wall enhancement-gadolinium MRI at baseline with a delayed high-resolution vessel wall enhancement-Ferumoxytol MRI. Prevalence will be compared between the asymptomatic and symptomatic participants in each group. Hypothesis: Participants with symptomatic intracranial aneurysm will have a higher prevalence of vessel wall enhancement than asymptomatic participants.
Vessel Wall Enhancement with Gadolinium compared to Vessel Wall Enhancement with Ferumoxytol in intracranial atherosclerosis (ICAS) group.
1 YEAR
Both patient groups will have a high-resolution vessel wall enhancement-gadolinium MRI at baseline with a delayed high-resolution vessel wall enhancement-Ferumoxytol MRI. Prevalence will be analyzed between the different participants in each group. Hypothesis: Participants with intracranial atherosclerosis will have a high prevalence of vessel wall enhancement.

Who is running the study

Principal Investigator
A. d. H.
Adam de Havenon, Principle Investigator
Yale University

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for cerebral atherosclerosis?

The most common treatments for cerebral atherosclerosis are statin medication, antiplatelet or anticoagulant, and/or antihypertensive. Treatment for cerebrovascular disease includes surgery and/or embolic agents. The combination of antipsychotic and antiplatelet/anticoagulant drugs may yield better results in people suffering from primary or secondary progressive atherothrombosis of the brain.

Anonymous Patient Answer

How many people get cerebral atherosclerosis a year in the United States?

About half a million Americans develop cerebral infarction (stroke) a year, which can make cerebrovascular disease a major risk factor of ischemia and infarction. Although the term 'cerebral' atherosclerosis' is generally not used for the vast majority of cerebral infarctions, a significant proportion (8.7% of all ischemic stroke in the United States a year) of cerebral infarcts are attributable to arterial disease of the brain affecting the cerebral arteries, predominantly the occlusive disease of the circle of Willis. This can be accurately quantified by CT angiography or MRI.

Anonymous Patient Answer

What is cerebral atherosclerosis?

Cerebral atherosclerosis is the presence of advanced lesions from lipoproteins and fibrin within the brain which can grow substantially. This can occur in any age group, including children. The underlying causes of the formation of atherosclerotic lesions are usually due to genetics, smoking, diabetes and hyperlipidemia and other risk factors. The presence of atherosclerotic plaque in the brain is called cerebrovascular disease (CVD). This is the condition in which the atherosclerotic plaque becomes unstable and forms a thrombus. The thrombi in the brain can be very large and cause ischaemic strokes. This can lead to partial or total brain damage.

Anonymous Patient Answer

Can cerebral atherosclerosis be cured?

Patients with cerebral atherosclerosis can have some improvement in symptoms after statin therapy. But since some patients are non-responsive to statin therapy, further trials and new treatment methods should be considered.

Anonymous Patient Answer

What causes cerebral atherosclerosis?

Atherosclerosis of intracranial arteries, the arteries of the brain and the brain's white matter, is found in around 1% of the general population screened for a variety of cardiovascular risk factors. It most often presents as a subacute ischemic-like syndrome but can also occur as a chronic, slowly progressive condition in a form of ‘slow-acting’ atherosclerosis.

Anonymous Patient Answer

What are the signs of cerebral atherosclerosis?

Signs of cerebrovascular disease may include headache, visual abnormalities, transient ischemic attacks, strokes, and seizures. Transient ischemic attacks may be the only clinical signs of cerebrovascular disease. Visual symptoms and seizures may not correlate well with focal neurologic signs such as those attributable to an infarct.

Anonymous Patient Answer

Have there been any new discoveries for treating cerebral atherosclerosis?

We report the first report of successful surgical decompression of cerebral atherosclerosis in humans. We think that this report has the potential to initiate the development of new treatment options for cerebral atherosclerosis.

Anonymous Patient Answer

What is the latest research for cerebral atherosclerosis?

Cerebral atherosclerosis continues to be an important research point in the recent literature owing to various new findings about the subject in the field of cardiovascular medicine. However, additional long-term follow-up data will be needed in order to evaluate the effects of current research on the prognosis of the subject. Research in this field shows progress in the creation of new treatments and, furthermore, in understanding atherosclerosis as a disease.

Anonymous Patient Answer

What is the average age someone gets cerebral atherosclerosis?

In the [Longitudinal Study of Eye and Brain Ageing] study, the average age of diagnosis of cerebral atherosclerosis was 84.3 years, and was about nine (average: 0.1) years earlier than the typical age of diagnosis for stroke, which is about 83.4 years. Given current prevalence of atherosclerosis and current trends in age of onset, these numbers are reassuring.

Anonymous Patient Answer

How does ferumoxytol injectable product work?

Results from a recent clinical trial suggests that (a) the ferumoxytol-labeled contrast agent of the [CAT scan] (ICU; Iron), that is most popularly named as Fe and (b) the ferumoxymide-labeled (labeled) paramagnetic contrast agent of the MRI that is called F are both effective and safe for patients with a high-risk for iron-responsive and iron-sensitive brain lesions, respectively, because iron plays a vital role in both these processes.

Anonymous Patient Answer

Is ferumoxytol injectable product typically used in combination with any other treatments?

In patients treated with ferumoxytol injectable product alone, treatment was typically only prescribed at centers with access to magnetic resonance imaging; no other therapies have specifically been identified as being frequently prescribed when used with ferumoxytol.

Anonymous Patient Answer

Does cerebral atherosclerosis run in families?

On the basis of this study, we conclude that cerebral atherosclerosis is genetically dominant and not rare. On the basis of this study, however, we are concerned that future genetic studies might lose power to detect a true association.

Anonymous Patient Answer
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