Image Detection of Impaired Microcirculatory Reperfusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT Perfusion.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Acute, Large Vessel Occlusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Stroke affects one patient every 40 seconds in the United States. It is most commonly caused by blood clots that develop in the blood vessels of the brain. These blood clots interrupt the normal flow of blood and oxygen to the nerve cells in the brain. When this occurs, the nerve cells can die, causing permanent damage to that area of the brain. That damage can result in loss of normal function to a patient's vision, strength, sensation, balance, or speech. These changes can remain permanent if blood flow is not restored to the brain. Thankfully, there are treatments available to help get rid of these blood clots. One of these treatments is a procedure to physically remove the blood clot causing stroke. This practice is now routinely done at all major stroke centers. Special imaging for stroke is now available at these major stroke centers. This imaging looks at blood flow in and around the area of brain that is dying. By performing these scans after the procedure, we can see that not all of brain is being saved by the procedure. That is a problem, because we know that saving brain cells can make a big difference in how patients recover from stroke. The purpose of this study is to determine which brain tissue will not get saved by blood clot removal. We will do this by using specialized imaging after the procedure. The study will discover if there is more brain tissue that can be saved after the procedure. Once we can determine this, our next steps will be looking at ways to save this tissue in the studies that follow. For example, we will look to see if medications can be given after the procedure to help save those brain areas. This study lays the groundwork for future studies to help save all the brain tissue we possibly can from dying during the stroke. This is our best chance of getting all patients affected by stroke the opportunity to live their best lives after stroke.
Detailed description
Image Detection of Impaired Microcirculatory Reperfusion (ID IMR) is a single center, prospective, feasibility study. It is designed to test the feasibility of utilizing post-thrombectomy CT Perfusion to identify a radiographic biomarker of IMR as well as other key variables associated with infarct expansion following complete angiographic reperfusion from thrombectomy in large vessel occlusion (LVO) stroke. The best biomarker identified from this study will be validated in a larger prospective study as a surrogate biomarker of IMR in LVO stroke.
Interventions
- Diagnostic test CT Perfusion
CT perfusion within 90 minutes of complete angiographic reperfusion
Primary outcome measures
- Feasibility of 90-minute CTP and 48-96-hr MRI [Time frame: From enrollment to 96 hours]
Eligibility criteria
Inclusion criteria
- Adults greater than or equal to 18 years of age
- Last known normal (LKN) within 24 hours
- Ischemic stroke due to anterior circulation LVO (intracranial internal carotid artery \[ICA\], proximal middle cerebral artery \[M1\], M1/M2 bifurcation, or proximal dominant M2 occlusion)
- mTICI2c or mTICI3 on digital subtracted angiography (DSA) following mechanical thrombectomy
Exclusion criteria
- Significant renal insufficiency (glomerular filtration rate \<30mg/ml/min2 while not on dialysis)
- Contraindication to iodinated contrast
- Contraindication to magnetic resonance imaging (e.g., pacemaker incompatibility)
- Prior significant stroke in same vascular territory ipsilateral stroke
- Tandem vessel occlusion (i.e., extracranial ICA and ipsilateral intracranial M1/M2 occlusion)
- Greater than 4 clot retrieval attempts
- Enrollment in another acute stroke interventional study (with the exception of thrombectomy device registries)
- Pregnancy
- Prisoners
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Cincinnati — Cincinnati
Identifiers
NCT: NCT07099599 · 2024-0526 · 24CDA1268532