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| Sponsor: | University of California, San Diego |
|---|---|
| Collaborators: |
University of Alabama at Birmingham University of California, Los Angeles |
| Information provided by: | University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00983749 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Device: External counterpulsation at a full pressure Device: External counterpulsation at sham-pressure |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | A Randomized, Controlled Phase 1 Study of External Counterpulsation as a Treatment for Acute Ischemic Stroke |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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Device: External counterpulsation at a full pressure
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.
|
|
Sham-pressure ECP: Sham Comparator
A 1-hour treatment of ECP at an inactive pressure (75mmHg)
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Device: External counterpulsation at sham-pressure
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama Hospital | |
| Birmingham, Alabama, United States, 35249 | |
| United States, California | |
| UCSD Medical Center | |
| San Diego, California, United States, 92103 | |
| UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | Kama Z Guluma, M.D. | University of California, San Diego |
More Information
| Responsible Party: | UCSDMED (University of California, San Diego) ( Kama Guluma, M.D. ) |
| Study ID Numbers: | SPOTRIAS Project 1, 3P50NS044148-06S1 |
| Study First Received: | September 23, 2009 |
| Last Updated: | September 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00983749 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
External Counterpulsation Counterpulsation, Diastolic Ultrasonography, Doppler, Transcranial Blood Flow Velocity Neurologic Deficit |
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Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Brain Ischemia |
Central Nervous System Diseases Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |