Hypertension Clinical Trial
— PREBPEDOfficial title:
Prognostic Relevance of Elevated Blood Pressure in the Emergency Department
| NCT number | NCT03954119 |
| Other study ID # | BPED1605 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2009 |
| Est. completion date | March 31, 2016 |
| Verified date | May 2019 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 300272 |
| Est. completion date | March 31, 2016 |
| Est. primary completion date | March 31, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | 20161231 | |
| Secondary | 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). | 2016-12-31 | |
| Secondary | 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). | 2016-12-31 | |
| Secondary | Incident Heart failure | I50 according to the International Classification of Diseases 10th edition (ICD-10). | 2016-12-31 | |
| Secondary | 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). | 2016-12-31 |
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