Blood PressurePREBPEDNCT03954119
Blood Pressure in the Emergency Department
An observational study of Blood Pressure and Hypertension, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Hypertension, Emergencies
- How many people
- 300,272 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Unselected adult patients attending the ED irrespective of chief complaint
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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
- Conditions
- Blood Pressure, Hypertension, Emergencies
- Keywords
- blood pressure, emergency department, atherosclerotic cardiovascular disease, myocardial infarction, stroke, long-term prognosis
- Medical subject headings
- Hypertension, Emergencies, Atherosclerosis, Myocardial Infarction, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Atherosclerotic Cardiovascular Disease (ASCVD)
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).
Measured: 20161231
Secondary outcomes (4)
Incident Myocardial infarction (MI)
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).
Measured: 2016-12-31
Incident All-cause stroke
Fatal and non-fatal all-cause stroke. I61, I630-I635, I638, I639, I64, according to the International Classification of Diseases 10th edition (ICD-10).
Measured: 2016-12-31
Incident Heart failure
I50 according to the International Classification of Diseases 10th edition (ICD-10).
Measured: 2016-12-31
Incident chronic kidney disease (CKD)
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).
Measured: 2016-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Jan 2009
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Svensson, Karolinska Institutet
- Investigators
- Per O Svensson, MD PhD, Principal investigator, Department of Clinical Science and Education, Södersjukhuset |
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954119
- Sponsor's protocol ID
- BPED1605
- Acronym
- PREBPED
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oras P, Habel H, Skoglund PH, Svensson P. Elevated Blood Pressure in the Emergency Department: A Risk Factor for Incident Cardiovascular Disease. Hypertension. 2020 Jan;75(1):229-236. doi: 10.1161/HYPERTENSIONAHA.119.14002. Epub 2019 Dec 2.
PubMed 31786971
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Relevance of Elevated Blood Pressure in the Emergency Department
- ClinicalTrials.gov ID
- NCT03954119
- Acronym / sponsor ID
- PREBPED / BPED1605
- Conditions
- Blood Pressure, Hypertension, Emergencies
- Keywords
- blood pressure, emergency department, atherosclerotic cardiovascular disease, myocardial infarction, stroke, long-term prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300,272 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected adult patients attending the ED irrespective of chief complaint
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
Incident Myocardial infarction (MI)
Time frame: 2016-12-31
Incident All-cause stroke
Time frame: 2016-12-31
Incident Heart failure
Time frame: 2016-12-31
Incident chronic kidney disease (CKD)
Time frame: 2016-12-31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Derived from this study: PubMed 31786971Oras P, Habel H, Skoglund PH, Svensson P. Elevated Blood Pressure in the Emergency Department: A Risk Factor for Incident Cardiovascular Disease. Hypertension. 2020 Jan;75(1):229-236. doi: 10.1161/HYPERTENSIONAHA.119.14002. Epub 2019 Dec 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per O Svensson, MD PhD principal investigator
Department of Clinical Science and Education, Södersjukhuset |
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Hypertension, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident Atherosclerotic Cardiovascular Disease (ASCVD) (time frame: 20161231). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03954119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.