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NCT Number: NCT05232240

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, BJ, 100053, China

Location status: Recruiting

Location contact

Xin Ma, MD, PhD

CONTACT

[email protected]

13501390691

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 3-year risk of Major Adverse Cardiovascular Event

    Time frame: 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

Secondary outcomes

  1. 90-day Functional Outcome

    Time frame: 90 days

    percentage of patients with modified Rankin Scale (mRS) scores (minimum 0 and maximum 5) 3 to 5, who are considered to be disabled

  2. 1-year rate of Major Adverse Cardiovascular Event

    Time frame: 1 year

    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

  3. 1-year rate of Ischemic Stroke

    Time frame: 1 year

    the rate of fatal and nonfatal ischemic stroke

  4. 1-year rate of Acute Coronary Syndrome

    Time frame: 1 year

    the rate of first documented fatal and nonfatal myocardial infarction and unstable angina

  5. 1-year rate of Cardiovascular Mortality

    Time frame: 1 year

    the rate of mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, and unobserved sudden death

  6. 3-year risk of Ischemic Stroke

    Time frame: 3 years

    the time of first documented fatal or nonfatal ischemic stroke

  7. 3-year risk of Acute Coronary Syndrome

    Time frame: 3 years

    the time of first documented fatal or nonfatal myocardial infarction or unstable angina

  8. 3-year risk of Cardiovascular Mortality

    Time frame: 3 years

    the time of mortality due to ischemic stroke, myocardial infarction, other cardiac diseases, or unobserved sudden death

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Ma, MD, PhD

CONTACT

[email protected]

13501390691

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Acronym: BPV-NhICVD

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 9, 2022
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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