Midodrine for Ischemic Stroke with Penumbra (MISP)

Principal Investigator: Adam  DeHavenon
Keywords: Stroke , Penumbra , blood pressure Department: Neurology
IRB Number: 00076683 Co Investigator:  
Specialty: Neurology, Neurology
Sub Specialties: Neuroimaging, Stroke
Recruitment Status: Recruiting

Contact Information

Ka-Ho Wong
ka-ho.wong@hsc.utah.edu
801-585-0541

Brief Summary

We propose an observational study of 20 patients with AIS. The proposed study will collect data on the primary and secodary endpoints of the future phase II study, in an observational manner. This will allow us to design the phase II trial through Bayesian simulation. The robust dataset from this study could lead to a phase II trial to determine midodrine's maximum tolerated dose, safety, and preliminary efficacy. This research has the potential to provide a novel beneficial treatment for ischemic stroke patients and help them build healthier lives with less permanent disability. This study will address the following two specific aims:

Aim 1: Investigate the of blood pressure mean and variability

We hypothesize that lower,  blood pressure variability, will be associated with improved outcome after AIS. We will record automatic blood pressure measurements every hour during hospital admission. 

Aim 2: Quantify changes in the penumbra and infarct volume with MRI

We hypothesize that  a baseline MRIs and a follow-up MRI 72hours laters will demonstrate changes in penumbra and infarct volume that will correlate with clinical outcome.  This will help us understand the effects of  the penumbra and infarct volume on stroke recovery.

Long-term Goals and Impact: This study will facilitate my development as a clinician scientist and result in a dataset that allows the design of an adequately powered phase II clinical trial, which will be the subject of an R21 application. In the long-term, a positive phase III trial could have clinically relevant implications for a large proportion of AIS patients who may benefit from medications to reduce blood pressure variability.

 

Inclusion Criteria

1.    Adult patients, ≥ 18 years old, with anterior circulation acute ischemic stroke on diffusion-weighted imaging (DWI) MRI, defined as predominant stroke burden in the frontal, parietal, or temporal lobes.

2.    Demonstrable neurologic deficit with NIHSS ≥ 2 at enrollment.

3.    Enrollment within 36 hours from stroke onset.

Exclusion Criteria

  1. Treatment with endovascular thrombectomy.
  2. Inability to tolerate MRI.
  3. Kidney disease with eGFR<45 ml/min/1.73m2, severe urinary retention, or end-stage renal disease on dialysis.
  4. Positive pregnancy test.
  5. Pre-stroke modified Rankin score of >2.
  6. Inability or unwillingness of subject or legal guardian/representative to give informed consent.
  7. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.