Safety Study of External Counterpulsation as a Treatment for Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if external counterpulsation (ECP) is feasible to
      perform, tolerable, and safe as a treatment for patients with acute ischemic stroke (i.e., a
      blockage of one of the arteries supplying a part of the brain), and to assess what type of
      effect it might have on 1) the velocity of blood flow in the arteries supplying the brain and
      2) stroke symptoms. The hypothesis of the study is that ECP will be feasible and safe to
      perform, and will be tolerable for patients with acute ischemic stroke at pressures that
      increase the velocity of arterial blood flow to the brain.
    

Detailed description: 
      A stroke is usually caused by a blockage of one of the arteries that carries blood to the
      brain. Sometimes with a stroke, there may be a small amount of blood flow that manages to get
      through or around the blockage, and it may be possible that the amount of damage from a
      stroke may be reduced by increasing this blood flow. External counterpulsation (ECP) is a
      procedure in which a machine uses electrical signals from the heart that are detectable on
      the surface of the body in order to time the inflation of cuffs (similar to a blood pressure
      cuff) that are wrapped around a patient's legs (calves, thighs and buttocks). Using a reading
      of the electrical activity from the patient's heart (an electrocardiogram, or ECG, monitor),
      the machine inflates the cuffs with air at just the right time during each heart beat, during
      diastole, in order to change the blood pressure in a way that has been shown to increase
      blood flow to the kidneys, skin, eyes, heart, and brain.

      In this study, patients presenting within the first 48 hours of an acute ischemic stroke
      (i.e., a blockage of one of the arteries supplying a part of the brain) will be randomly
      assigned to either of (1) a 1-hour treatment of external counterpulsation (ECP) applied at a
      pressure that is typically therapeutic, or (2) a 1-hour treatment of ECP at a minimal
      pressure in a control group. ECP-induced changes in brain artery flow velocity will be
      assessed with an ultrasound prior to and then during ECP in each group, and an optimal
      pressure that results in an augmentation of flow velocity will be determined. A neurological
      exam will be performed prior to, during, and after ECP in each group, in order to assess any
      changes in stroke symptoms related to ECP. Patients will be followed to 30 days. The main
      goal of this trial is to evaluate if ECP is safe and feasible to use as a treatment for
      stroke. In addition, the trial will enable an assessment of whether or not ECP increases
      blood flow to the brain or affects the neurological symptoms of a patient with a stroke.
    

Intervention name(s): Full-pressure ECP; Sham-pressure ECP
Intervention type(s): Device; Device
Intervention description(s): A one-hour treatment of ECP at full pressure, which will be applied in a tiered, dose-escalating manner, starting at 200mmHg and increasing up to 300mmHg based on assessments made.; A one-hour treatment of ECP at an inactive pressure, which will be applied at 75mmHg and kept there for the hour while assessments are made.
Other intervention name(s): External counterpulsation; External counterpulsation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: External Counterpulsation; Counterpulsation, Diastolic; Ultrasonography, Doppler, Transcranial; Blood Flow Velocity; Neurologic Deficit