Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Blood Pressure in the Emergency Department (PREBPED)

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.
 
ClinicalTrials.gov Identifier: NCT03954119
Recruitment Status : Completed
First Posted : May 17, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Per Svensson, Karolinska Institutet

Brief Summary:
This is a cohort study based on a large sample (> 600 000) of emergency department (ED) visits from two university hospital EDs. Information on incident disease after discharge from the ED will be collected through linkage to Swedish national in-patient register and cause of death register. The importance of blood pressure measured at the ED for incident atherosclerotic cardiovascular disease during long term follow up will be studied by Cox-regression analysis

Condition or disease
Blood Pressure Hypertension Emergencies

Layout table for study information
Study Type : Observational
Actual Enrollment : 300272 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Relevance of Elevated Blood Pressure in the Emergency Department
Actual Study Start Date : January 1, 2009
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incident Atherosclerotic Cardiovascular Disease (ASCVD) [ Time Frame: 20161231 ]
    ASCVD was defined as a combination of fatal coronary heart disease (CHD ), (I210-I214, I219, I220, I221, I228, I229, I461 or I469), non-fatal MI (I210-I214, I219, I220, I221, I228 or I229), fatal and non-fatal ischemic stroke (I630-I635, I638 or I639). According to the International Classification of Diseases 10th edition (ICD-10).


Secondary Outcome Measures :
  1. Incident Myocardial infarction (MI) [ Time Frame: 2016-12-31 ]
    Fatal and non-fatal Myocardial infarction (MI) I210-I214, I219, I220, I221, I228 or I229. I200 were included if combined with intervention procedure codes FNA-FNG, FNW) , according to the International Classification of Diseases 10th edition (ICD-10).

  2. Incident All-cause stroke [ Time Frame: 2016-12-31 ]
    Fatal and non-fatal all-cause stroke. I61, I630-I635, I638, I639, I64, according to the International Classification of Diseases 10th edition (ICD-10).

  3. Incident Heart failure [ Time Frame: 2016-12-31 ]
    I50 according to the International Classification of Diseases 10th edition (ICD-10).

  4. Incident chronic kidney disease (CKD) [ Time Frame: 2016-12-31 ]
    I120, I131 E10.2-E10.5,E10.7,E11.2-E11.5, E11.7,E12.2-E12.5,E12.7, E13.2- E13.5,E13.7,E14.2-E14.5, E14.7 N032-037, N052-057, N18, N19, N250, Z49,Z49.0,Z49.1, Z49.2,Z49.01, Z49.02,Z49.3,Z49.31,Z49.32, Z99.2, I77.0 Z94.0 according to the International Classification of Diseases 10th edition (ICD-10).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Unselected adult patients attending the ED irrespective of chief complaint
Criteria

Inclusion Criteria:

  • Attending the Emergency departments (ED) at Karolinska University hospital in Solna or Huddinge during the specified time period
  • Record of blood pressure measurement from the ED-visit

Exclusion Criteria:


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 ClinicalTrials.gov identifier (NCT number): NCT03954119


Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Per O Svensson, MD PhD Department of Clinical Science and Education, Södersjukhuset |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Per Svensson, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03954119    
Other Study ID Numbers: BPED1605
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Per Svensson, Karolinska Institutet:
blood pressure
emergency department
atherosclerotic cardiovascular disease
myocardial infarction
stroke
long-term prognosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Disease Attributes
Pathologic Processes