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Blood Pressure Level and Prognosis in Acute Stroke

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was:  Recruiting
Information provided by:
UPECLIN HC FM Botucatu Unesp Identifier:
First received: July 5, 2010
Last updated: July 4, 2011
Last verified: July 2011

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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Blood Pressure Level and Lethality in Acute Phase of Stroke : Observational Prospective Study.

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

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

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

Estimated Enrollment: 266
Study Start Date: February 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Natalia Eduarda Furlan, UPECLIN Identifier: NCT01195350     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-47
Study First Received: July 5, 2010
Last Updated: July 4, 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 processed this record on August 16, 2017