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Blood Pressure Level and Prognosis in Acute Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by UPECLIN HC FM Botucatu Unesp.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01195350
First received: July 5, 2010
Last updated: July 4, 2011
Last verified: July 2011
  Purpose

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
Stroke

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physical incapacity [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute isquemic or hemorragic stroke admitted in ICU.

Criteria

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 ClinicalTrials.gov identifier: NCT01195350

Locations
Brazil
Unidades de Terapia Intensiva do Hospital das Clínicas da Faculdade de Medicina de Botucatu Recruiting
Botucatu, São Paulo, Brazil
Contact: Natalia Furlan       na-furlan@hotmail.com   
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
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

No publications provided

Responsible Party: Natalia Eduarda Furlan, UPECLIN
ClinicalTrials.gov 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
Health Authority: Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014