Examining blood pressure variability in non-hypertensive patients with ischemic cerebrovascular disease

Blood Pressure Variability in Non-hypertensive Patients With Ischemic Cerebrovascular Disease

This study looks at how changes in blood pressure over time affect non-hypertensive patients with ischemic cerebrovascular disease to see if it can help predict their risk of future health problems.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, BJ)
• Trial ID: NCT05232240 on ClinicalTrials.gov

What this trial studies

This observational study focuses on non-hypertensive patients diagnosed with ischemic cerebrovascular disease (ICVD), such as ischemic stroke or transient ischemic attack. Participants will undergo ambulatory 24-hour blood pressure monitoring at baseline and again one year later to assess blood pressure variability (BPV) and its relationship with vascular risk. The study aims to identify factors influencing BPV and explore how BPV may affect the risk of future vascular events in this patient population. Data will be collected through clinical assessments, imaging, and patient self-reports over a three-year follow-up period.

Who should consider this trial

Good fit: Ideal candidates are non-hypertensive individuals who have recently experienced an ischemic stroke or transient ischemic attack.

Not a fit: Patients with a confirmed diagnosis of hypertension or those currently receiving anti-hypertensive treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for blood pressure in non-hypertensive patients with ICVD, potentially reducing the risk of future vascular events.

How similar studies have performed: While studies have explored blood pressure variability in hypertensive populations, this specific focus on non-hypertensive patients with ICVD is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed as ischemic stroke or transient ischemic attack (TIA), with confirmation of computed tomography or magnetic resonance imaging.
2. Less than 90 days after onset of ischemic stroke or TIA symptoms.
3. The blood pressure measured 5\~90 days after the ICVD onset without any anti-hypertension treatment is less than 140/90 mmHg (an average of ≥2 readings obtained on ≥ 2 occasions after emptying bladder, relaxing for more than 5 min, and avoiding caffeine, exercise, or smoking for at least 30 min before measurement).
4. Consent to participate in the study.

Exclusion Criteria:

1. A definite diagnosis of hypertension.
2. Under anti-hypertension treatment.
3. Worsening neurological conditions.
4. With a National Institute of Health Stroke Scale score more than 5 points.
5. Intracranial hemorrhage.
6. Autonomic failure.
7. With malignant tumors or poor organ functions or hematologic diseases, whose estimated life expectancy is less than 3 years.
8. With contraindications to ambulatory 24-hour blood pressure monitoring or fail to finish the examination at baseline.
9. Mental disease.
10. Pregnant.

Where this trial is running

Beijing, BJ

• Xuanwu Hospital, Capital Medical University — Beijing, Bj, China (Recruiting)

Study contacts

• Study coordinator: Xin Ma, MD, PhD

Conditions Ischemic Cerebrovascular Disease; Blood Pressure Variability; ischemic stroke; transient ischemic attack; non-hypertensive; blood pressure variability; vascular risk