Blood Pressure Variability in Non-hypertensive Patients With Ischemic Cerebrovascular Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood pressure variability measured by ambulatory 24-hour blood pressure monitoring
Diagnostic testThe 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Non-hypertensive patients with Ischemic Cerebrovascular Disease1 intervention
Trial outcomes
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
Time frame
3 yearsSecondary outcomes
1
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
Time frame
90 days2
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
Time frame
1 year3
1-year rate of Ischemic Stroke
the rate of fatal and nonfatal ischemic stroke
Time frame
1 year4
1-year rate of Acute Coronary Syndrome
the rate of first documented fatal and nonfatal myocardial infarction and unstable angina
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov