Blood Pressure Variability in Non-hypertensive Patients With Ischemic Cerebrovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 3-year risk of Major Adverse Cardiovascular Event
研究概览
简要总结
This study is a single-center prospective cohort of patients with ischemic cerebrovascular disease (ICVD) who have not met the diagnostic criteria for hypertension. Ambulatory 24-hour blood pressure monitoring (ABPM) will be performed at baseline and one year after the enrollment. The primary purpose of the study is to delineate the relationship of blood pressure variability (BPV) with the risk of composite vascular events in non-hypertensive patients with ICVD. The factors related to BPV, as well as the potential modulators of the associations between BPV and vascular risk, will be further explored among these patients.
详细描述
Hypertension is one of the most important risk factors of ischemic cerebrovascular disease (ICVD), while various blood pressure variability (BPV) indices are immerging as novel prognostic indicators independent of the blood pressure level. However, the BPV profiles without hypertension have not been specifically observed. Considering the great importance of blood pressure management in ICVD, more research is needed to clarify whether and how BPV will increase the vascular risk in non-hypertensive patients with ICVD. This prospective cohort study will be helpful to invoke an early management of blood pressure in patients with ICVD before the clinical establishment of hypertension.
All eligible non-hypertensive patients hospitalized for ICVD will be consecutively enrolled in this cohort. Blood pressure measurements are obtained with ambulatory 24-hour blood pressure monitoring (ABPM) every 20 minutes during day-time (6:00-22:00) and every 30 minutes during night-time (22:00-6:00) at baseline and one year after the enrollment. The clinical, imaging and laboratory information will be collected at baseline. During an estimated 3-year follow-up, the vessel-related diagnostic or monitoring procedures, treatment, functional status and new vascular events will be recorded by web-based patients' self-reports and investigators' regular telephone visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as ischemic stroke or transient ischemic attack (TIA), with confirmation of computed tomography or magnetic resonance imaging.
- •Less than 90 days after onset of ischemic stroke or TIA symptoms.
- •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).
- •Consent to participate in the study.
排除标准
- •A definite diagnosis of hypertension.
- •Under anti-hypertension treatment.
- •Worsening neurological conditions.
- •With a National Institute of Health Stroke Scale score more than 5 points.
- •Intracranial hemorrhage.
- •Autonomic failure.
- •With malignant tumors or poor organ functions or hematologic diseases, whose estimated life expectancy is less than 3 years.
- •With contraindications to ambulatory 24-hour blood pressure monitoring or fail to finish the examination at baseline.
- •Mental disease.
结局指标
主要结局
3-year risk of Major Adverse Cardiovascular Event
时间窗: 3 years
the time of first documented cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death), ischemic stroke, myocardial infarction or unstable angina
次要结局
- 1-year rate of Major Adverse Cardiovascular Event(1 year)
- 1-year rate of Cardiovascular Mortality(1 year)
- 1-year rate of Acute Coronary Syndrome(1 year)
- 90-day Functional Outcome(90 days)
- 3-year risk of Ischemic Stroke(3 years)
- 3-year risk of Acute Coronary Syndrome(3 years)
- 3-year risk of Cardiovascular Mortality(3 years)
- 1-year rate of Ischemic Stroke(1 year)
研究者
Xin Ma
Principal investigator
Xuanwu Hospital, Beijing