Active not recruitingOBSERVATIONAL

Symptomatic Carotid Outcomes Registry

This study, called the Symptomatic Carotid Outcomes Registry, aims to understand how effective current medical treatments are at preventing strokes in people who have had a mini-stroke or stroke caused by a narrowed neck artery. Over 30 years ago, important studies were done, but treatments have improved a lot since then, with new medications like statins and better blood pressure drugs. This study wants to fill that knowledge gap. Researchers are specifically looking to see if, with today's intensive medical therapy alone, the chance of having another stroke within a year can be kept below 5% for patients with certain low-risk features. It's an observational study, meaning no new treatments are given; it just closely watches current patient care.

At a glance

Status

Active not recruiting

Sponsor

University of Maryland, Baltimore

Enrolment target

114

Start

01 Aug 2022

Estimated completion

01 Dec 2026

Carotid Stenosis Ischemic Stroke Transient Ischemic Attack

What is this study about?

Imagine the main artery in your neck (called the carotid artery) brings blood to your brain. Sometimes, this artery can get narrowed, like a partially blocked pipe. This narrowing, called carotid stenosis, can increase your risk of having a stroke or a mini-stroke (TIA).

Over 30 years ago, some very important studies helped doctors understand how to treat this condition. However, medicine has come a long way since then! We now have better medications, like statins to control cholesterol, newer strong anti-clotting drugs, and improved blood pressure medicines. These older studies didn't include these new treatments, so there's a gap in our understanding: how well do our *current* best medical treatments work to prevent strokes in people with narrowed neck arteries?

This study, called the Symptomatic Carotid Outcomes Registry, wants to answer that question. It aims to see if, by just using the best available medical treatments we have today (what they call ‘Intensive Medical Therapy’), the risk of having a stroke within one year can be kept very low – specifically, below 5% – for people with narrowed neck arteries who also have other features that suggest they are at a lower risk for another stroke. It's important to know that this study isn't testing new drugs; it's simply observing and gathering information on how well current, standard treatments are working.

Key takeaways

This study helps understand how well modern medicines prevent strokes.
It focuses on people with narrowed neck arteries who've had a stroke or mini-stroke.
No new treatments are tested; it observes current, standard medical care.
Participation involves completing three short surveys over one year.
Your involvement could help improve future stroke prevention for others.

Who may be eligible?

To be part of this study, you would generally need to be at least 40 years old and have recently had a stroke or mini-stroke (TIA) that is linked to a significant narrowing (between 50% and 99%) in one of your carotid arteries.

Crucially, you would also need to have at least one feature that suggests you might be at a lower risk for another stroke. This could be things like only having temporary vision loss (amaurosis fugax), being female, or if your most recent stroke or TIA was more than a week ago. Factors like certain brain imaging results showing no new damage, or special artery scans showing no tiny clots, could also indicate a lower risk.

However, there are also reasons why you might not be able to join. For example, if you have certain heart conditions that cause strokes, severe dementia, severe bleeding problems, or if you regularly misuse alcohol or drugs. Also, if you need certain powerful blood thinners for other health reasons, or if you have a known allergy to common anti-clotting medicines like aspirin or clopidogrel, you wouldn't be able to participate. This study is not for people whose carotid narrowing is due to something other than the usual 'hardening of the arteries', or for those whose last stroke-like event was more than six months ago.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 40 years old?
Have you recently had a stroke or mini-stroke (TIA) linked to a narrowed neck artery?
Do you have certain features that suggest a lower risk for another stroke (e.g., female, only temporary vision loss, or your last event was over a week ago)?
Do you *not* have certain serious conditions like severe dementia, severe bleeding problems, or specific heart conditions that cause strokes?
Are you able to take standard anti-clotting medication like aspirin or clopidogrel?
Was your most recent stroke or mini-stroke less than 6 months ago?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's fairly straightforward. There won't be any special experimental treatments or procedures that you wouldn't already be receiving as part of your standard medical care. Your doctors will continue to manage your treatment as they normally would, focusing on what they believe is best for you.

Your involvement would mostly include providing information for the study. This means you would be asked to complete a survey or questionnaire when you start the study, again after 6 months, and finally at 12 months. This allows the researchers to gather important details about your health and treatments over a year. All the information collected will be kept safe and secure in a special research database for this study. The total duration of your active participation, where you'd be completing surveys, would be for one year.

Potential risks and benefits

Since this study only observes the medical care you would already be receiving, there are no direct new medical risks from participating beyond those already associated with your routine treatment. The main 'risk' if you can call it that, would be the time and effort involved in completing the surveys. The potential benefit is that by sharing your health information, you contribute to a better understanding of how effective current medical treatments are for preventing strokes. This could help improve care for many future patients. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (18)

Hartford Hospital
Verified postcode
Hartford, United States
Emory University Hospital
Verified postcode
Atlanta, United States
Northwestern Memorial Hospital
Verified postcode
Chicago, United States
Rush Medical Center
Verified postcode
Chicago, United States
University of Iowa
Verified postcode
Iowa City, United States
University of Maryland Medical Center
Verified postcode
Baltimore, United States
Baystate Medical Center
Verified postcode
Springfield, United States
University of Massachusetts Medical Center
Verified postcode
Worcester, United States
University of Rochester
Verified postcode
Rochester, United States
Rhode Island Hospital
Verified postcode
Providence, United States
Baylor Medicine
Verified postcode
Houston, United States
Calgary Health Sciences Center
Verified postcode
Calgary, Canada

Common questions

What is 'Intensive Medical Therapy'?

It means receiving the best available standard medical treatments today for your condition, which often includes medications to lower cholesterol, control blood pressure, and prevent blood clots, as recommended by your doctor.

Will I get new, untested drugs in this study?

No, this study only observes the care you are already receiving. You won't be given any experimental treatments or drugs not already approved and used by doctors.

How long will I be involved in the study?

You will be asked to complete surveys at the start, at 6 months, and again at 12 months, meaning your active participation will be for one year.

What happens to my personal information?

All the information collected from you will be entered into a secure research database. Your privacy and data security are very important.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting the care you receive from your doctors.