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

NCT05232240 | Recruiting

• 1 other identifier: BPV-NhICVD
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cerebrovascular Disease; Blood Pressure Variability

Keywords

ischemic stroke; transient ischemic attack; non-hypertensive; blood pressure variability; vascular risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 90-day Functional Outcome

  90 days

• 1-year rate of Major Adverse Cardiovascular Event

  1 year

• 1-year rate of Ischemic Stroke

  1 year

• 1-year rate of Acute Coronary Syndrome

  1 year

• 1-year rate of Cardiovascular Mortality

  1 year

Study Arms (1)

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

Interventions

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

Non-hypertensive patients with Ischemic Cerebrovascular Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, BJ, 100053, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cells and plasma

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Central Study Contacts

Xin Ma, MD, PhD

CONTACT

13501390691; maxin118@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 9, 2022
• Study Start: February 14, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 14, 2022

Record last verified: 2022-02

Locations

CN (1)