Safety Study of External Counterpulsation as a Treatment for Acute Ischemic Stroke

NCT00983749 | Completed Phase 1 Results

• 2 other identifiers: SPOTRIAS Project 13P50NS044148-06S1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stroke

Keywords

External Counterpulsation; Counterpulsation, Diastolic; Ultrasonography, Doppler, Transcranial; Blood Flow Velocity; Neurologic Deficit

Outcome Measures

Primary Outcomes (2)

• Feasibility and Tolerability of External Counterpulsation

  The first primary outcome measure was tolerability and feasibility. Tolerance was defined as the absence of any indications to stop the procedure or reduce the pressure to a non-therapeutic level. Feasibility was defined in the full-pressure group as the sustained (at least 30 minutes) tolerance of any pressure capable of causing a 15% augmentation of MFV in 90% of subjects, and defined in the sham-pressure group as the sustained tolerance of the sham pressure in all subjects.

  During one hour of treatment

• 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)

  Safety was evaluated by the incidence of serious adverse events (SAEs) or acute neurological deterioration in relation to the study device and/or procedures at 30 days, the incidence of acute symptomatic hemorrhage on repeat imaging at 24 hours, the incidence of all adverse events (AEs) in the first 48 hours, and mortality at 30 days. The National Institutes of Health Stroke Scale (NIHSS) is a stroke severity scale, based on examination, that goes from 0 (no deficit) to a maximum of 42. Acute neurological deterioration - which was captured as a serious adverse event - was defined as a ≥4-point increase on the NIHSS, or a ≥2-point decline in level of consciousness item 1a on the NIHSS, or a new neurological deficit, or clinically significant worsening of motor function lasting more than 8 hours and attributable to a neurological entity. Symptomatic intracranial hemorrhage was defined as new hemorrhage on CT that was associated with acute neurological deterioration.

  30 days

Study Arms (2)

Full-pressure ECP

EXPERIMENTAL

Patients in the "Full-pressure ECP" arm receive a 1-hour treatment of ECP at full pressure, which will be applied in a tiered, dose-escalating manner up to 300mmHg, while assessments are made.

Device: Full-pressure ECP

Sham-pressure ECP

SHAM COMPARATOR

A 1-hour treatment of ECP at an inactive pressure (75mmHg)

Device: Sham-pressure ECP

Interventions

Full-pressure ECP DEVICE

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.

Also known as: External counterpulsation

Full-pressure ECP

Sham-pressure ECP DEVICE

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.

Also known as: External counterpulsation

Sham-pressure ECP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead
• University of Alabama at Birmingham: collaborator
• University of California, Los Angeles: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (3)

University of Alabama Hospital

Birmingham, Alabama, 35249, United States

Location

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Stroke; Heart Murmurs; Neurologic Manifestations

Interventions

Counterpulsation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Assisted Circulation; Surgical Procedures, Operative

Results Point of Contact

• Title: Kama Guluma, M.D.
• Organization: Department of Emergency Medicine, University of California San Diego Health System

kguluma@ucsd.edu

619-543-6463

Study Officials

• Kama Z Guluma, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 28, 2016
• Results First Posted: June 28, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)