NCT02675972

Brief Summary

Previous studies on the association between blood pressure variation (BPV) in acute ischemic stroke and functional outcomes yield conflicting result. The obscured definition and measurement of BPV engenders considerable confounding factors, making it difficult to interpret. We aim to investigate the predictive role of 24-hour BPV on early outcomes in acute non-cardiogenic ischemic stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

January 27, 2016

Last Update Submit

May 15, 2017

Conditions

Keywords

stroke, blood pressure, prognosis

Outcome Measures

Primary Outcomes (1)

  • early neurological deterioration

    NIHSS increase by 4 points or continuous consciousness deterioration

    7 days after admission

Secondary Outcomes (2)

  • good functional outcome at 14 days

    up to 14 days in-hospital

  • good functional outcome at 3 months

    3 months

Study Arms (2)

patient with poor outcome

modified Rankin scale≥3

patients with favorable outcome

modified Rankin scale\<3

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

acute ischemic stroke patients with 72 hour after onset

You may qualify if:

  • acute ischemic stroke

You may not qualify if:

  • cardiogenic cerebral embolisms due to atrial fibrillation, pronounced heart valve diseases or valve replacement operation;
  • isolated sensory symptoms, isolated visual changes, isolated dizziness, or vertigo, without explicit MRI-DWI evidence for acute cerebral infarcts;
  • coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease which would influence patients' independent functions .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguan Peoples' Hospital

Dongguan, Guangdong, 523029, China

Location

Related Publications (1)

  • Shi Z, Li ES, Zhong JS, Yuan JL, Li LR, Zheng CW. Predictive Significance of Day-to-Day Blood Pressure Variability in Acute Ischemic Stroke for 12-Month Functional Outcomes. Am J Hypertens. 2017 May 1;30(5):524-531. doi: 10.1093/ajh/hpx005.

Biospecimen

Retention: SAMPLES WITHOUT DNA

fasting glucose, creatine, BNP, CRP,BUN,cholesterol, LDL,HDL

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • zhu Shi, PhD,MD

    dongguan peoples' hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy director of neurology department

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 5, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

April 1, 2016

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Under regulations of local ethic committee, data concerning individual privacy are not allowed to release.

Locations