External Counterpulsation Therapy for Symptomatic and Severe Steno-occlusive Disease of Intracranial Internal Carotid or Middle Cerebral Artery and Impaired Cerebral Vasodilatory Reserve

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Intracranial stenosis is prevalent among Asians and constitute a common cause of cerebral ischemia. While the best medical therapy carries stroke recurrence rates in access of 10% per year, intracranial stenting was associated with unacceptable peri-procedural ischemic events. Cerebral ischemic events are strongly related to the severity of intracranial stenosis, being high in patients with severe intracranial stenosis with poor vasodilatory reserve. Enhanced External Counter-Pulsation (EECP) therapy is known to improve myocardial perfusion by facilitating the development of collateral blood vessels in the heart. The investigators hypothesize that EECP therapy may be useful in patients with severe stenosis of intracranial internal carotid (ICA) or middle cerebral artery (MCA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Singapore
National University Hospital
RECRUITING
Singapore
Contact Information
Primary
Lily YH Wong, RN
lily_wong@nuhs.du.sg
+6567722517
Time Frame
Start Date: 2019-01-08
Estimated Completion Date: 2024-11-30
Participants
Target number of participants: 130
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: National University of Singapore
Collaborators: National University Health System, Singapore

This content was sourced from clinicaltrials.gov

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