- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954119
Blood Pressure in the Emergency Department (PREBPED)
May 16, 2019 updated by: Per Svensson, Karolinska Institutet
Prognostic Relevance of Elevated Blood Pressure in the Emergency Department
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300272
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Unselected adult patients attending the ED irrespective of chief complaint
Description
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:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
20161231
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
2016-12-31
|
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).
|
2016-12-31
|
Incident Heart failure
Time Frame: 2016-12-31
|
I50 according to the International Classification of Diseases 10th edition (ICD-10).
|
2016-12-31
|
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).
|
2016-12-31
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Per O Svensson, MD PhD, Department of Clinical Science and Education, Södersjukhuset |
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2009
Primary Completion (ACTUAL)
March 31, 2016
Study Completion (ACTUAL)
March 31, 2016
Study Registration Dates
First Submitted
May 15, 2019
First Submitted That Met QC Criteria
May 15, 2019
First Posted (ACTUAL)
May 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 20, 2019
Last Update Submitted That Met QC Criteria
May 16, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BPED1605
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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