Phase 1
N=23
Safety Study of External Counterpulsation as a Treatment for Acute Ischemic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00983749 ↗Enrolled (actual)
23
Serious AEs
4.4%
Results posted
Jun 2016
Primary outcome: Primary: Feasibility and Tolerability of External Counterpulsation — 12; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Full-pressure ECP (Device); Sham-pressure ECP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Tolerability of External Counterpulsation |
12; 9 | — |
| PRIMARY Safety (Including Endpoints Such an Increase NIHSS During or Immediately After ECP, and Acute Hemorrhage on Repeating Imaging, Serious Adverse Events Related to ECP, Mortality) |
12; 8; 0; 0; 0; 0 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT00983749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.