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
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Device: Enhance External Counterpulsation Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|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.|
|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|
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.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921827
|Contact: Lily YH Wong, RNemail@example.com|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119228|
|Contact: Lily YH Wong, RN 67722517 firstname.lastname@example.org|
|Principal Investigator:||Vijay K Sharma, MD||National University, Singapore|