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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00983749
First received: September 23, 2009
Last updated: May 19, 2016
Last verified: May 2016
Results First Received: January 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Device: Full-pressure ECP
Device: Sham-pressure ECP

  Participant Flow
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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
  Description
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  
NOT COMPLETED     0     0  

Period 2:   Follow-up Phase (Hospital DC to 30 Days)
    Full-pressure ECP     Sham-pressure ECP  
STARTED     13     10  
COMPLETED     12     7  
NOT COMPLETED     1     3  
Lost to Follow-up                 1                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Full-pressure ECP     Sham-pressure ECP     Total  
Number of Participants  
[units: participants]
  13     10     23  
Age  
[units: years]
Median (Inter-Quartile Range)
  57  
  (50 to 66)  
  57  
  (55 to 60)  
  57  
  (52 to 65)  
Gender  
[units: participants]
     
Female     6     2     8  
Male     7     8     15  



  Outcome Measures
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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
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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
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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
e-mail: kguluma@ucsd.edu



Responsible Party: Kama Guluma, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00983749     History of Changes
Other Study ID Numbers: SPOTRIAS Project 1
3P50NS044148-06S1 ( US NIH Grant/Contract Award Number )
Study First Received: September 23, 2009
Results First Received: January 7, 2016
Last Updated: May 19, 2016
Health Authority: United States: Food and Drug Administration