Ischemic Stroke, AcuteID IMRNCT07099599
Image Detection of Impaired Microcirculatory Reperfusion
An observational study of Ischemic Stroke, Acute and Large Vessel Occlusion, run by University of Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute, Large Vessel Occlusion
- What is being tested?
- CT Perfusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thrombectomy-treated subjects with mTICI2c or 3 reperfusion of a previously occluded anerior circulation vessel.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Enrollment in another acute stroke interventional study (with the exception of thrombectomy device registries)
- Pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christina Mihova contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Christina Mihova, MS, PMP, 513-558-2968, mihovaca@ucmail.uc.edu
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke, Acute, Large Vessel Occlusion
- Being tested
- CT Perfusion
- Keywords
- No Reflow, Microcirculatory Reperfusion, Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT PerfusionDiagnostic test
CT perfusion within 90 minutes of complete angiographic reperfusion
| Study group | Role | What they receive |
|---|---|---|
| Thrombectomy-Treated Subjects with Anterior Circulation Vessel Occlusion | Patients with anterior circulation LVO or equivalent stroke treated with mechanical thrombectomy. Receives: Diagnostic Test: CT Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of 90-minute CTP and 48-96-hr MRI
The primary outcome is feasibility determined by greater than or equal to 80% of the planned sample size for whom technically adequate 90-minute CTP and 48-96 hour MRI key parameters (baseline penumbra volume [Tmax greater than 4 seconds], predicted infarct core volume [CBF greater than 30%], and follow-up infarct volume [MRI DWI]) are usable.
Measured: From enrollment to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start30 Sep 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Yasmin Aziz, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099599
- Sponsor's protocol ID
- 2024-0526
- Other IDs
- 24CDA1268532
- Acronym
- ID IMR
- Status last verified
- Jul 2025
- First submitted
- 16 Mar 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Perfusion parameters from CTP
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Detection of Impaired Microcirculatory Reperfusion
- ClinicalTrials.gov ID
- NCT07099599
- Acronym / sponsor ID
- ID IMR / 2024-0526
- Conditions
- Ischemic Stroke, Acute, Large Vessel Occlusion
- Keywords
- No Reflow, Microcirculatory Reperfusion, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 1 Aug 2025 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thrombectomy-Treated Subjects with Anterior Circulation Vessel Occlusion | – | Diagnostic Test: CT PerfusionPatients with anterior circulation LVO or equivalent stroke treated with mechanical thrombectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thrombectomy-treated subjects with mTICI2c or 3 reperfusion of a previously occluded anerior circulation vessel.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT PerfusionCT perfusion within 90 minutes of complete angiographic reperfusion | Diagnostic test | Thrombectomy-Treated Subjects with Anterior Circulation Vessel Occlusion |
Primary outcome
Feasibility of 90-minute CTP and 48-96-hr MRI
Time frame: From enrollment to 96 hours
The primary outcome is feasibility determined by greater than or equal to 80% of the planned sample size for whom technically adequate 90-minute CTP and 48-96 hour MRI key parameters (baseline penumbra volume [Tmax greater than 4 seconds], predicted infarct core volume [CBF greater than 30%], and follow-up infarct volume [MRI DWI]) are usable.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Yes. Perfusion parameters from CTP
Related trials for Ischemic Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Christina Mihova contact
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 Ischemic Stroke, Acute and Large Vessel Occlusion, run by University of Cincinnati 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmin N Aziz, MD (513-688-5405, azizyn@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of 90-minute CTP and 48-96-hr MRI (time frame: From enrollment to 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025.