Blood Pressure Level and Prognosis in Acute Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01195350
Recruitment Status : Unknown
Verified July 2011 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was:  Recruiting
First Posted : September 6, 2010
Last Update Posted : July 6, 2011
Information provided by:
UPECLIN HC FM Botucatu Unesp

Brief Summary:

Stroke is the leading cause of mortality in Brazil. Strict blood pressure control in chronic phase is the major measure to primary and secondary prevention, but in acute phase is not clear the best blood pressure level. Few studies demonstrate a "U" relationship between blood pressure and lethality; nevertheless any Brazilian study has addressed this issue.

This is a prospective observational study on the relationship between BP and mortality in the acute phase of stroke. The study will be conducted in the Adult ICU of HC-UNESP. Will be analyzed 266 patients aged 18 years and of both sexes admitted to the ICU with a diagnosis of hemorrhagic and ischemic stroke. Participants will be divided into three groups according to the initial PA present:

Group A: Patients with systolic BP of entry below 140 mmHg; Group B: Patients with systolic BP of entry between 140 and 180 mmHg; Group C: patients with systolic BP greater than 180 mmHg entry. Multiple logistic regression analysis will be done to verify the association of blood pressure and lethality adjusted to confounding variables.

Condition or disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 266 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Blood Pressure Level and Lethality in Acute Phase of Stroke : Observational Prospective Study.
Study Start Date : February 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011


Primary Outcome Measures :
  1. Death [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Physical incapacity [ Time Frame: one month ]
    Modified Rankin scale will be applied within one month after the cerebrovascular event.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute isquemic or hemorragic stroke admitted in ICU.

Inclusion criteria:

  • hemorrhagic and ischemic
  • admitted in ICU

Exclusion criteria:

  • Age below 18 years
  • Subarachnoid hemorrhage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01195350

Unidades de Terapia Intensiva do Hospital das Clínicas da Faculdade de Medicina de Botucatu Recruiting
Botucatu, São Paulo, Brazil
Contact: Natalia Furlan   
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Principal Investigator: Natalia E Furlan, Bacharel Faculdade de Medicina de Botucatu
Study Chair: Rodrigo Bassan, MSc Faculdade de Medicina de Botucatu
Study Director: Luis C Martin, Phd Faculdade de Medicina de Botucatu

Responsible Party: Natalia Eduarda Furlan, UPECLIN Identifier: NCT01195350     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-47
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by UPECLIN HC FM Botucatu Unesp:
Ischemic Stroke
Hemorrhagic Stroke
Blood pressure
Intensive care

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases