Trial Outcomes & Findings for Safety Study of External Counterpulsation as a Treatment for Acute Ischemic Stroke (NCT NCT00983749)
NCT ID: NCT00983749
Last Updated: 2016-06-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
During one hour of treatment
Results posted on
2016-06-28
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Acute Phase (Enrollment to Hospital DC)
STARTED
|
13
|
10
|
|
Acute Phase (Enrollment to Hospital DC)
COMPLETED
|
13
|
10
|
|
Acute Phase (Enrollment to Hospital DC)
NOT COMPLETED
|
0
|
0
|
|
Follow-up Phase (Hospital DC to 30 Days)
STARTED
|
13
|
10
|
|
Follow-up Phase (Hospital DC to 30 Days)
COMPLETED
|
12
|
7
|
|
Follow-up Phase (Hospital DC to 30 Days)
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Follow-up Phase (Hospital DC to 30 Days)
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Safety Study of External Counterpulsation as a Treatment for Acute Ischemic Stroke
Baseline characteristics by cohort
| Measure |
Full-pressure ECP
n=13 Participants
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
n=10 Participants
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
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
57 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During one hour of treatmentThe 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.
Outcome measures
| Measure |
Full-pressure ECP
n=13 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Feasibility and Tolerability of External Counterpulsation
|
12 participants
|
9 participants
|
PRIMARY outcome
Timeframe: 30 daysSafety 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.
Outcome measures
| Measure |
Full-pressure ECP
n=13 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
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)
Patients with at least one AE
|
12 participants
|
8 participants
|
|
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)
Patients with device or treatment-related SAE
|
0 participants
|
0 participants
|
|
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)
Symptomatic hemorrhage at 24 hour
|
0 participants
|
0 participants
|
|
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)
Acute neurological deterioration
|
0 participants
|
0 participants
|
|
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)
Deaths reported out to 30 days
|
0 participants
|
0 participants
|
Adverse Events
Full-pressure ECP
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Sham-pressure ECP
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Full-pressure ECP
n=13 participants at risk
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
n=10 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Transient ischaemic attack
|
7.7%
1/13 • Number of events 2 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
Other adverse events
| Measure |
Full-pressure ECP
n=13 participants at risk
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
n=10 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Micturition urgency
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Cardiac disorders
Bradycardia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
General disorders
Discomfort
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
General disorders
Pyrexia
|
30.8%
4/13 • Number of events 4 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Investigations
Blood glucose increased
|
15.4%
2/13 • Number of events 2 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/13 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/13 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Nervous system disorders
Transient ischaemic attack
|
7.7%
1/13 • Number of events 2 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/13 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease exacerbated
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
15.4%
2/13 • Number of events 2 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Vascular disorders
Carotid artery thrombosis
|
7.7%
1/13 • Number of events 1 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
0.00%
0/10 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
|
Vascular disorders
Hypertension
|
46.2%
6/13 • Number of events 6 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
50.0%
5/10 • Number of events 5 • Adverse events were collected out to 48 hours, and Serious Adverse Events (SAEs) were collect out to 30 days.
|
Additional Information
Kama Guluma, M.D.
Department of Emergency Medicine, University of California San Diego Health System
Phone: 619-543-6463
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place