Using External Counterpulsation Therapy for Severe Intracranial Stenosis
External Counterpulsation Therapy for Symptomatic and Severe Steno-occlusive Disease of Intracranial Internal Carotid or Middle Cerebral Artery and Impaired Cerebral Vasodilatory Reserve
This study is testing whether Enhanced External Counterpulsation therapy can help Asian patients with severe narrowing of brain arteries who have had a recent stroke or TIA by improving blood flow and reducing the chance of more strokes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | National University of Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT03921827 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Enhanced External Counterpulsation (EECP) therapy in patients with severe stenosis of the intracranial internal carotid artery (ICA) or middle cerebral artery (MCA) who have experienced a recent stroke or transient ischemic attack (TIA). The approach aims to improve cerebral blood flow and reduce the risk of recurrent ischemic events by enhancing collateral circulation. Participants will be monitored for their cerebral vasodilatory reserve and treated with EECP therapy to assess its effectiveness in preventing further strokes. The study focuses on Asian patients, who are at a higher risk for intracranial stenosis and related complications.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 years old who have had a recent stroke or TIA and exhibit severe stenosis of the ICA or MCA with impaired cerebral vasodilatory reserve.
Not a fit: Patients with atrial fibrillation, severe heart failure, or other significant cardiovascular issues may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the recurrence of strokes in patients with severe intracranial stenosis.
How similar studies have performed: While the use of EECP therapy is established for myocardial perfusion, its application in treating intracranial stenosis is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore
- National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Vijay K Sharma, MD — National University of Singapore
- Study coordinator: Lily YH Wong, RN
- Email: lily_wong@nuhs.du.sg
- Phone: +6567722517
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.