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

NCT ID: NCT05232240

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2028-02-29

Brief Summary

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.

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.

Conditions

Ischemic Cerebrovascular Disease; Blood Pressure Variability

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

blood pressure variability measured by ambulatory 24-hour blood pressure monitoring

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Xin Ma

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, BJ, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Ma, MD, PhD

Role: CONTACT

maxin118@hotmail.com

13501390691

Facility Contacts

Xin Ma, MD, PhD

Role: primary

maxin118@hotmail.com

13501390691

Other Identifiers

BPV-NhICVD

Identifier Type: -

Identifier Source: org_study_id