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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
Sponsor:
Collaborator:
National University Health System, Singapore
Information provided by (Responsible Party):
VIJAY KUMAR SHARMA, National University, Singapore

Brief 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).

Condition or disease Intervention/treatment Phase
Ischemic Stroke Device: Enhance External Counterpulsation Therapy Not Applicable

  Show Detailed Description

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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
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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
Criteria

Inclusion Criteria:

  1. 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).
  2. Age >21 years

Exclusion Criteria:

  1. Patients with atrial fibrillation/ arrhythmias.
  2. Within 2 weeks of cardiac catheterization or arterial puncture at femoral puncture site.
  3. Decompensated heart failure , usually class 3 or 4
  4. LV EF <30%
  5. Moderate or severe AR
  6. Persistent and uncontrolled hypertension (BP persistently >160/100 mmHg)
  7. Bleeding diathesis
  8. Active thrombophlebitis/ venous disease of lower limbs
  9. Severe lower extremity vaso-occlusive disease
  10. Presence of a documented aortic aneurysm/ dissection requiring surgical repair
  11. Pregnancy

Information from the National Library of Medicine

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


Contacts
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Contact: Lily YH Wong, RN +6567722517 lily_wong@nuhs.du.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Lily YH Wong, RN    67722517    lily_wong@nuhs.edu.sg   
Sponsors and Collaborators
National University, Singapore
National University Health System, Singapore
Investigators
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Principal Investigator: Vijay K Sharma, MD National University, Singapore

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Responsible Party: VIJAY KUMAR SHARMA, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT03921827     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by VIJAY KUMAR SHARMA, National University, Singapore:
MCA; ICA; vasodilatory reserve; EECP; intracranial stenosis