External Counterpulsation Therapy for Severe Steno-occlusive Intracranial Stenosis
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ClinicalTrials.gov Identifier: NCT03921827 |
Recruitment Status :
Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Ischemic Stroke | Device: Enhance External Counterpulsation Therapy | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized clinical trial with 1:1 allocation to EECP therapy and best medical therapy |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Outcome will be assessed by independent assessors for stroke/TIA recurrence within 6 months as well as change in cerebral vasodilatory reserve on acetazolamide challenged HMPAO- SPECT of brain. |
Primary Purpose: | Treatment |
Official Title: | External Counterpulsation Therapy for Symptomatic and Severe Steno-occlusive Disease of Intracranial Internal Carotid or Middle Cerebral Artery and Impaired Cerebral Vasodilatory Reserve |
Actual Study Start Date : | January 8, 2019 |
Estimated Primary Completion Date : | January 7, 2023 |
Estimated Study Completion Date : | May 7, 2023 |
Arm | Intervention/treatment |
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Experimental: EECP therapy
Half of the study sample will be allocated to EECP therapy (35 sessions) of 1-hour each. Acetazolamide challenged HMPAO-SPECT will be performed before randomization and repeated 2-months after the completion of EECP therapy. MRI of the brain would be performed after completion of EECP therapy to document any silent stroke.
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Device: Enhance External Counterpulsation Therapy
EECP therapy would be administered to this group for 1-hour a day for a total of 35 sessions |
No Intervention: Best Medical Therapy
This group will receive the best medical therapy according to our institutional practice and as per the recommendations of American Stroke Association.
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- Improvement in cerebral vasodilatory reserve [ Time Frame: at baseline and after 2 months of the completion of EECP therapy ]To evaluate whether Enhanced External Counter-Pulsation (EECP) therapy would lead to a change in cerebral vasodilatory reserve (CVR) by at least 4% in patients with severe and recently symptomatic stenosis of intracranial carotid (ICA) or middle cerebral artery (MCA).
- Stroke TIA/recurrence [ Time Frame: at 6 months ]To evaluate the impact of EECP on recurrence of cerebral ischemic event in patients with severe and recently symptomatic stenosis of ICA or MCA.
- Impact of EECP on cognition [ Time Frame: at 6 months ]To evaluate the impact of EECP on change in neurocognitive performance by at least 2 points (60 minutes protocol suggested by NINDS harmonization workshop) in patients with severe and recently symptomatic stenosis of ICA or MCA.

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with recent stroke/TIA and severe stenosis of intracranial ICA or MCA and impaired CVR within previous three months but not before 3 weeks after acute stroke. This is to differentiate between patients with a long-standing fixed-stenosis from patients with partially recanalized intracranial artery (masquerading as severe stenosis).
- Age >21 years
Exclusion Criteria:
- Patients with atrial fibrillation/ arrhythmias.
- Within 2 weeks of cardiac catheterization or arterial puncture at femoral puncture site.
- Decompensated heart failure , usually class 3 or 4
- LV EF <30%
- Moderate or severe AR
- Persistent and uncontrolled hypertension (BP persistently >160/100 mmHg)
- Bleeding diathesis
- Active thrombophlebitis/ venous disease of lower limbs
- Severe lower extremity vaso-occlusive disease
- Presence of a documented aortic aneurysm/ dissection requiring surgical repair
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921827
Contact: Lily YH Wong, RN | +6567722517 | lily_wong@nuhs.du.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore, 119228 | |
Contact: Lily YH Wong, RN 67722517 lily_wong@nuhs.edu.sg |
Principal Investigator: | Vijay K Sharma, MD | National University, Singapore |
Responsible Party: | VIJAY KUMAR SHARMA, Associate Professor, National University, Singapore |
ClinicalTrials.gov Identifier: | NCT03921827 |
Other Study ID Numbers: |
NUSingapore_EECP |
First Posted: | April 19, 2019 Key Record Dates |
Last Update Posted: | April 19, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | After completion of the study, the team would be happy to share the anonymised database to any study with a similar protocol |
Supporting Materials: |
Study Protocol Clinical Study Report (CSR) |
Time Frame: | After completion of the study |
Access Criteria: | The data will be shared via email to the PIs of studies with a similar protocol |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
MCA; ICA; vasodilatory reserve; EECP; intracranial stenosis |