The Recovery and Outcomes from StrokE (ROSE) study

What is a stroke?

A stroke occurs when a blood vessel that carries blood to the brain from the heart is either blocked or bursts. As a result, the part of the brain the blood vessel was supplying does not get the blood it needs and starts to die.

What is ICH?

An intracerebral hemorrhage (ICH) is a type of stroke where the blood vessel ruptures or bursts inside the brain (Figure 1). Even though these types of stroke are less than 20 percent of all strokes, ICH causes half of all stroke-related deaths. Patients who survive an ICH are often seriously disabled.

What is the purpose of the ROSE study?

Some patients after ICH recover nearly back to normal again while others are left devastated by the stroke. This may be true with the same size and location of hemorrhage. If we can identify the different proteins or biologic mechanisms that helps people to recover, we may be able to apply it to all ICH patients to improve recovery. This may relate to inflammation, new blood vessel growth or preserving the brain’s functions.

The Recovery and Outcomes from StrokE (ROSE) study uses a special kind of MRI that looks at the connections within the brain. Figure 2 gives an example of what the tracts of the brain look like on this MRI and what sort of damage it does to the fibers of the brain (Panel B Yellow Arrow).

In addition, ICH can burst into the ventricles causing hydrocephalus, also known as expansion of the ventricles of the brain. Figure 3 shows an example of how the tracts around the ventricles can be stretched by hydrocephalus. If we can determine the critical amount of stretching that leads to permanent injury, we may be able to determine interventions that reduce that risk while avoiding treatments in those that are likely to recover.

The ROSE study will be the largest study of its kind to look at tract imaging or DTI in an ICH population and to performed detailed evaluation including measurements of strength, thinking, coordination and balance.

Frequently asked questions

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The ROSE Project is seeking participants who are 18 years old or older and have had a spontaneous ICH. You do not have to be able to provide your own consent (permission) to be in the study. If you can’t give your own consent to be in the study, a person who is allowed to make healthcare decisions for you (known as a proxy) can give consent.
You (or your loved one) will be in the study for about six months. If eligible for the ROSE study, you (or your loved one) will undergo an hour long examination that will test items like your strength, balance, and cognition. We will re-test this in the future (at about 3 months and 6 months) to see how well you have recovered. In addition, ROSE study patients will undergo an MRI that will look at the tracts of the brain to see if they are still intact, damaged, or destroyed. If you’ve already had a clinical MRI performed close to the time of the research MRI, it’s likely that only 10-15 minutes more is required.

After your first interview, you will have a small sample of your blood taken for genetic testing. Your blood samples will be used for research purposes only. They will be specially processed and stored in a biorepository (a collection of biological samples and health-related information) that can be used for future research. Your name and other information about you will be removed from your sample and it will be given a code number when it is provided to researchers.
You are not required to participate in the study. If you choose to participate, you may withdraw at any time in the future. Ideally, patients should be enrolled as close to the onset of hemorrhage as possible. However, patients have up to 45 days after the hemorrhage to enroll into ROSE study. It also takes several days to arrange the MRI so it is best to have enrollment completed several days in advance of the deadline. Ideally, patients may be enrolled while hospitalized.
Being in the ROSE Project will not affect the care you get in the hospital. You will have the same doctors and get the same treatment whether you choose to be in the study or not. If the MRI is to performed in the hospital, we will try to schedule it so that it doesn’t interfere with your care. If you can’t have the MRI while hospitalized, we will bring you back for the MRI to be performed as an outpatient.
Although there is no direct medical benefit to you, the study doctors hope that what they learn from this research study will help them identify new tests and treatments for ICH in order to help future generations.
For the ROSE study, the only medical risks are related to the MRI such as claustrophobia or minor discomfort from lying flat for 45 minutes to an hour which we will try to address when you are having the MRI. The physical examinations have minimal risk but may be tiring.

There is a possible risk that information you share during the interview or the genetic testing done on your blood could be lost or stolen. Extra protections and safeguards are made to help keep data and biologic samples safe and the study is protected by a Certificate of Confidentiality from the Department of Health and Human Services.
There are no costs to participate in the ROSE Project. The blood draw and research MRI are done at no cost to you. If the MRI was also ordered as part of your clinical care, that portion of it will be billed to your insurance. You are responsible for your ongoing medical care.
The ROSE Project is a group effort involving researchers at the following sites:
  • University of Cincinnati
  • Baptist Health Louisville
  • Columbia University
  • Duke University
  • Houston Methodist
  • University of Chicago-Illinois
  • University of Maryland (Baltimore)
  • Wake Forest University
The ROSE study is funded by grants from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health.

Want to enroll?

Because we need to perform analyses at roughly the time of their stroke, only those patients within 45 days of their hemorrhage are eligible for the study and there are other criteria for enrollment. If you are near one of the sites (see ‘Where is the study being conducted?), you may already have been approached by one of the investigators. If not, please feel free to contact us through the email below. Please leave as much information in the email as possible to be able to get back with you and in particular, what city you are in so that we can have the right center call you. Thank you for considering! With your help, we may be able to find new treatments for ICH!

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Our other studies

The Recovery and Outcomes from StrokELongitudinal Assessment With Neuroimaging (ROSE-LAWN)
The Recovery and Outcomes from StrokELongitudinal Assessment With Neuroimaging (ROSE-LAWN) study is the first long-term follow-up of patients with ICH that repeats the special MRI used at baseline (in the ROSE study) as well as performing follow-up with a comprehensive examination in a time frame of years after the ICH. Our purpose is to identify what causes some patients to develop a progressive decline in their cognition or thinking.