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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00983749
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : June 28, 2016
Last Update Posted : June 28, 2016
University of Alabama at Birmingham
University of California, Los Angeles
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Kama Guluma, University of California, San Diego

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Device: Full-pressure ECP
Device: Sham-pressure ECP

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled 23 patients with symptoms and signs of acute middle cerebral artery (MCA) ischemic stroke presenting within 48 hours of onset at three academic medical centers in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Before randomization, all patients underwent duplex ultrasound scanning of the legs to rule out deep vein thrombosis (DVT), along with an assessment of temporal window adequacy for transcranial doppler (TCD); patients meeting these criteria were randomly assigned to one of two treatment arms (all the patients that were enrolled met these criteria).

Reporting Groups
Full-pressure ECP Patients in the "Full-pressure ECP" arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made.
Sham-pressure ECP Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.

Participant Flow for 2 periods

Period 1:   Acute Phase (Enrollment to Hospital DC)
    Full-pressure ECP   Sham-pressure ECP
STARTED   13   10 
COMPLETED   13   10 

Period 2:   Follow-up Phase (Hospital DC to 30 Days)
    Full-pressure ECP   Sham-pressure ECP
STARTED   13   10 
COMPLETED   12   7 
Lost to Follow-up                1                3 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Feasibility and Tolerability of External Counterpulsation   [ Time Frame: During one hour of treatment ]

2.  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)   [ Time Frame: 30 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Kama Guluma, M.D.
Organization: Department of Emergency Medicine, University of California San Diego Health System
phone: 619-543-6463

Responsible Party: Kama Guluma, University of California, San Diego Identifier: NCT00983749     History of Changes
Other Study ID Numbers: SPOTRIAS Project 1
3P50NS044148-06S1 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2009
First Posted: September 24, 2009
Results First Submitted: January 7, 2016
Results First Posted: June 28, 2016
Last Update Posted: June 28, 2016