Intensive blood pressure control after stroke
European Blood Pressure Intensive Control After Stroke - Pilot Trial
This study is testing if home blood pressure monitoring and remote check-ins can help people who had a stroke keep their blood pressure under control better than regular care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University College Dublin Academic / other |
| Locations | 1 site (Dublin) |
| Trial ID | NCT04647292 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a larger clinical trial that compares home blood pressure monitoring and telemonitoring with medication adjustments to standard care for patients who have experienced an ischemic stroke or transient ischemic attack. Participants will be randomized to receive either standard care or the intervention involving home monitoring and telemonitoring. The hypothesis is that this approach may lead to better blood pressure control, which is crucial for preventing future strokes and heart attacks. The study will recruit patients with systolic blood pressure of 140 mmHg or higher within a specific time frame after their qualifying event.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older who have experienced an ischemic stroke or high-risk transient ischemic attack with elevated blood pressure.
Not a fit: Patients with contraindications to intensive blood pressure lowering or those who have experienced a hemorrhagic stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of recurrent strokes and improve overall cardiovascular health for patients.
How similar studies have performed: Previous studies have shown promising results with home blood pressure monitoring and telemonitoring, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥40 2. Ischaemic stroke1, high-risk TIA, proven by imaging (brain CT/MRI) 3. Living at home and independent (walking without the aid of another person, but may have some help for daily activities) 4. SBP≥140mmHg at entry (average of 2 measures, seated, in the same arm, after resting alone in office for 10 minutes) 5. Qualifying event between 30 days and 1 year of randomisation 6. Glomerular filtration rate (eGFR) greater than or equal to 50ml/min/m2 (within 3 months of randomisation) 7. Medically-stable and capable of participating in a randomised trial, including home BP measures, in the opinion of the study physician 8. Willing to provide informed consent (no surrogate consent will apply) Exclusion Criteria: 1. SBP \<110mmHg after 3 minutes of standing or other contra-indication to intensive SBP lowering in opinion of treating clinician (eg. Orthostatic symptoms, syncope or pre syncope, recurrent falls) 2. Qualifying stroke due to intracerebral haemorrhage (ICH), cardio-embolism or other defined causes (eg. dissection, endocarditis, other specified) 3. Severe stenosis or occlusion of large cranio-cervical artery (\>70% stenosis/occlusion of cervical carotid, vertebral, or Circle of Willis artery) 4. Unlikely to comply with study procedures due to severe or fatal comorbid illness (eg. dementia, active malignancy, severe frailty) or other factor (eg. inability to travel) 5. Pregnancy or breastfeeding
Where this trial is running
Dublin
- Mater Misericordiae University Hospital — Dublin, Ireland (Recruiting)
Study contacts
- Study coordinator: Katrina Tobin
- Email: katrina.tobin@ucd.ie
- Phone: +353 1 716 4576
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.