Safety Study of External Counterpulsation as a Treatment for Acute Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Full-pressure ECP; Sham-pressure ECP
Intervention description: 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.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: External Counterpulsation; Counterpulsation, Diastolic; Ultrasonography, Doppler, Transcranial; Blood Flow Velocity; Neurologic Deficit

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults between the ages of 18 and 85, inclusive

          -  Symptoms consistent with acute ischemic stroke, with a measurable neurological deficit
             at presentation

          -  Ability to initiate external counterpulsation within 48 hours of stroke onset

          -  No evidence of hemorrhage on CT scan or MRI

          -  MCA distribution stroke: a total or partial anterior circulation infarct (TACI or PACI
             by Oxfordshire criteria) consistent with MCA distribution ischemia, or a lacunar
             stroke felt by the investigator to possibly involve a deep perforating branch in the
             MCA territory (LACI by Oxfordshire criteria)

        Exclusion Criteria:

          -  Rapidly resolving stroke symptoms consistent with a transient ischemic attack

          -  Severe stroke defined as an NIHSS > 22

          -  Intracranial hemorrhage (SAH, EDH, SDH, IPH, hemorrhagic conversion) on CT scan

          -  Brain tumor or brain abscess on CT scan or MRI

          -  Presentation consistent with subarachnoid hemorrhage (such as a sudden, severe
             thunderclap headache, or an associated third nerve palsy)

          -  History of cerebral aneurysm, AVM, or hemorrhagic stroke

          -  Either treatment or planned treatment of current stroke with standard thrombolytic
             therapy (intravenous or intra-arterial) or neurothrombectomy

          -  History of lower limb amputation above the ankle

          -  History of untreated aortic dissection

          -  History or suspicion of thoracic or abdominal aortic aneurysm

          -  Known significant anomaly of the heart, aorta, or great vessels that would be
             complicated by elevated diastolic pressures.

          -  BP > 180/100 that remains so after minimal treatment (such as one or two doses of an
             antihypertensive agent, or as determined by the investigator)

          -  History of non-trivial aortic regurgitation, or any symptomatic valvular heart disease
             determined by the investigator to be at risk of worsening on ECP

          -  Significant symptomatic congestive heart failure (orthopnea, CHF-related dyspnea, or
             rales and jugular venous distention on exam) or a left ventricular ejection fraction
             known to be <30%

          -  Diagnosis of significant lower extremity peripheral vascular occlusive disease (PVOD),
             or symptomatic PVOD as determined by the investigator (especially symptoms of
             claudication)

          -  Phlebitis, stasis ulcer, severe varicosities

          -  Diagnosis of DVT within the past month, or current symptoms strongly suggestive of new
             DVT, such as asymmetric calf or leg swelling, discomfort, or erythema (to be evaluated
             by screening duplex)

          -  Pacemaker or automated implanted defibrillator (AICD)

          -  A cardiac dysrhythmia (such as atrial fibrillation or atrial flutter, or frequent
             premature ventricular contractions (PVCs) or premature atrial contractions (PACs) as
             determined by the investigator) that would interfere with ECP triggering

          -  Pregnancy (as determined by a urine pregnancy test in females of child-bearing age)

          -  Known coagulopathy, thrombocytopenia with platelet count < 100,000, or taking warfarin
             with an INR > 2.0.

          -  History positive for chronic low back pain, radiculopathy suggestive of herniated
             lumbar disc, or related surgery

          -  Known collagen vascular disease

          -  Obesity to a degree (as determined by the investigator) that would prevent proper
             placement and/or activation of counterpulsation cuffs

          -  Any psychological, social, or legal condition that would interfere with the ability of
             the patient or his or her surrogate to give Informed Consent and/or his or her
             capacity to comply with all study requirements, including the necessary time
             commitment

          -  An inadequate temporal window for TCD insonation.

          -  Currently involved or have been involved in a clinical trial within the last 30 days.