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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00983749
First Posted: September 24, 2009
Last Update Posted: June 28, 2016
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.
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
Results First Submitted: January 7, 2016  
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
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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 
Overall Participants Analyzed 
[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 ]

Measure Type Primary
Measure Title Feasibility and Tolerability of External Counterpulsation
Measure Description 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.
Time Frame During one hour of treatment  

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.

Measured Values
   Full-pressure ECP   Sham-pressure ECP 
Participants Analyzed 
[Units: Participants]
 13   10 
Feasibility and Tolerability of External Counterpulsation 
[Units: Participants]
 12   9 

No statistical analysis provided for Feasibility and Tolerability of External Counterpulsation



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 ]

Measure Type Primary
Measure Title 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)
Measure Description 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.
Time Frame 30 days  

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.

Measured Values
   Full-pressure ECP   Sham-pressure ECP 
Participants Analyzed 
[Units: Participants]
 13   10 
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) 
[Units: Participants]
   
Patients with at least one AE   12   8 
Patients with device or treatment-related SAE   0   0 
Symptomatic hemorrhage at 24 hour   0   0 
Acute neurological deterioration   0   0 
Deaths reported out to 30 days   0   0 

No statistical analysis provided for 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)




  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
No text entered.


  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 ( 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