Blood Pressure Variability in Non-hypertensive Patients With Ischemic Cerebrovascular Disease (BPV-NhICVD)

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Cerebrovascular Disease; Blood Pressure Variability
• Intervention / Treatment: Diagnostic test: blood pressure variability measured by ambulatory 24-hour blood pressure monitoring

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients are diagnosed as ischemic cerebrovascular disease (ICVD) and less than 90 days after the onset of ischemic stroke or transient ischemic attack. The patients have no definite diagnosis of hypertension, and are not under anti-hypertension treatment. 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Non-hypertensive patients with Ischemic Cerebrovascular Disease; The patients are diagnosed as ischemic cerebrovascular disease (ICVD) and less than 90 days after the onset of ischemic stroke or transient ischemic attack. The patients have no definite diagnosis of hypertension, and are not under anti-hypertension treatment. 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).

Diagnostic test: blood pressure variability measured by ambulatory 24-hour blood pressure monitoring; The ambulatory 24-hour blood pressure monitoring will be performed at baseline and one year after the enrollment. Various blood pressure variability characteristics will be obtained from these examinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year risk of Major Adverse Cardiovascular Event	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	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day Functional Outcome	percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled	90 days
1-year rate of Major Adverse Cardiovascular Event	the rate of cardiovascular mortality (any mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, and unobserved sudden death), ischemic stroke, myocardial infarction and unstable angina	1 year
1-year rate of Ischemic Stroke	the rate of fatal and nonfatal ischemic stroke	1 year
1-year rate of Acute Coronary Syndrome	the rate of first documented fatal and nonfatal myocardial infarction and unstable angina	1 year
1-year rate of Cardiovascular Mortality	the rate of mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, and unobserved sudden death	1 year
3-year risk of Ischemic Stroke	the time of first documented fatal or nonfatal ischemic stroke	3 years
3-year risk of Acute Coronary Syndrome	the time of first documented fatal or nonfatal myocardial infarction or unstable angina	3 years
3-year risk of Cardiovascular Mortality	the time of mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death	3 years

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Anticipated): February 1, 2027
• Study Completion (Anticipated): February 1, 2028

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: January 30, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: ischemic stroke; transient ischemic attack; blood pressure variability; vascular risk; non-hypertensive
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ischemia; Cerebrovascular Disorders
• Other Study ID Numbers: BPV-NhICVD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No