External Counterpulsation Therapy for Severe Steno-occlusive Intracranial Stenosis

NCT03921827 | Completed DMC FDA Device

• 1 other identifier: NUSingapore_EECP
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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).

Conditions

Ischemic Stroke

Keywords

MCA; ICA; vasodilatory reserve; EECP; intracranial stenosis

Outcome Measures

Primary Outcomes (1)

• Improvement in cerebral vasodilatory reserve

  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).

  at baseline and after 2 months of the completion of EECP therapy

Secondary Outcomes (2)

• Stroke TIA/recurrence

  at 6 months

• Impact of EECP on cognition

  at 6 months

Study Arms (2)

EECP therapy

EXPERIMENTAL

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

Best Medical Therapy

NO INTERVENTION

This group will receive the best medical therapy according to our institutional practice and as per the recommendations of American Stroke Association.

Interventions

Enhance External Counterpulsation Therapy DEVICE

EECP therapy would be administered to this group for 1-hour a day for a total of 35 sessions

EECP therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Health System, Singapore: collaborator
• National University of Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

Location

Related Publications (1)

• Sharma VK, Gopinathan A, Tan BYQ, Loh PH, Hung J, Tang D, Chua C, Chan ACY, Ong JJY, Chin A, Jing M, Goh Y, Sunny S, Keat CH, Ka Z, Pandya S, Wong LYH, Chen JT, Yeo LLL, Chan BPL, Teoh HL, Sinha AK. Enhanced external counter pulsation therapy in patients with symptomatic and severe intracranial steno-occlusive disease: a randomized clinical trial protocol. Front Neurol. 2023 May 30;14:1177500. doi: 10.3389/fneur.2023.1177500. eCollection 2023.

  PMID: 37325226 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vijay K Sharma, MD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized clinical trial with 1:1 allocation to EECP therapy and best medical therapy

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 19, 2019
• Study Start: January 8, 2019
• Primary Completion: March 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

SG (1)