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

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ClinicalTrials.gov Identifier: NCT00983749
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : June 28, 2016
Last Update Posted : June 28, 2016
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

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
Enrollment 23
Recruitment Details 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 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).
Arm/Group Title Full-pressure ECP Sham-pressure ECP
Hide Arm/Group Description 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. 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.
Period Title: Acute Phase (Enrollment to Hospital DC)
Started 13 10
Completed 13 10
Not Completed 0 0
Period Title: Follow-up Phase (Hospital DC to 30 Days)
Started 13 10
Completed 12 7
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             3
Arm/Group Title Full-pressure ECP Sham-pressure ECP Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 13 10 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 13 participants 10 participants 23 participants
57
(50 to 66)
57
(55 to 60)
57
(52 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
6
  46.2%
2
  20.0%
8
  34.8%
Male
7
  53.8%
8
  80.0%
15
  65.2%
1.Primary Outcome
Title Feasibility and Tolerability of External Counterpulsation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full-pressure ECP Sham-pressure ECP
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 13 10
Measure Type: Number
Unit of Measure: participants
12 9
2.Primary Outcome
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full-pressure ECP Sham-pressure ECP
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 13 10
Measure Type: Number
Unit of Measure: 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
Time Frame Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Full-pressure ECP Sham-pressure ECP
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Full-pressure ECP Sham-pressure ECP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Full-pressure ECP Sham-pressure ECP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      0/10 (0.00%)    
Nervous system disorders     
Transient ischaemic attack  1  1/13 (7.69%)  2 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive airways disease exacerbated  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Full-pressure ECP Sham-pressure ECP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/13 (92.31%)      8/10 (80.00%)    
Cardiac disorders     
Bradycardia  1  1/13 (7.69%)  1 1/10 (10.00%)  1
Ear and labyrinth disorders     
Ear pain  1  0/13 (0.00%)  0 1/10 (10.00%)  1
General disorders     
Discomfort  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Non-cardiac chest pain  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Pyrexia  1  4/13 (30.77%)  4 0/10 (0.00%)  0
Investigations     
Blood glucose increased  1  2/13 (15.38%)  2 0/10 (0.00%)  0
Haematocrit decreased  1  0/13 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/13 (0.00%)  0 1/10 (10.00%)  1
Pain in extremity  1  0/13 (0.00%)  0 1/10 (10.00%)  1
Shoulder pain  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Nervous system disorders     
Aphasia  1  0/13 (0.00%)  0 1/10 (10.00%)  1
Headache  1  1/13 (7.69%)  1 1/10 (10.00%)  1
Hypoaesthesia  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Transient ischaemic attack  1  1/13 (7.69%)  2 0/10 (0.00%)  0
Psychiatric disorders     
Depression  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Renal and urinary disorders     
Micturition urgency  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Reproductive system and breast disorders     
Menorrhagia  1  0/13 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive airways disease exacerbated  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Tachypnoea  1  2/13 (15.38%)  2 2/10 (20.00%)  2
Vascular disorders     
Carotid artery thrombosis  1  1/13 (7.69%)  1 0/10 (0.00%)  0
Hypertension  1  6/13 (46.15%)  6 5/10 (50.00%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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
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