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Blood pressure variability in PRoFESS and development of incident stroke
Proposal
2099
Title of Proposed Research
Blood pressure variability in PRoFESS and development of incident stroke
Lead Researcher
Adam de Havenon
Affiliation
University of Utah, Department of Neurology
Funding Source
American Heart Association, Scientist Development Grant
Potential Conflicts of Interest
None
Data Sharing Agreement Date
11 July 2018
Lay Summary
Increased blood pressure variability, independent of mean blood pressure, is harmful in the acute period after ischemic and hemorrhagic stroke. Likewise, increased outpatient “visit-to-visit variability" of blood pressure (VVV) has been linked with a higher risk of stroke, coronary artery disease, diabetes mellitus, and chronic kidney disease. The etiology of increased VVV is not fully understood, but recent data has shown that it is not due to medication non-adherence. Ischemic stroke remains one of the leading causes of death and disability in the United States, despite advances in primary and secondary stroke prevention. Over 700,000 Americans a year suffer stroke, with more than 8 million American stroke survivors. A secondary analysis of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) trial showed increased VVV predisposed to the development of incident stroke in that cohort. We believe that VVV is a viable treatment target and seek to demonstrate the association between increased VVV and incident stroke events in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial. PRoFESS is a unique cohort to study this association. Unlike ALLHAT, patients enrolled in PRoFESS had recent noncardioembolic ischemic stroke and, as a result, a much higher rate of ischemic stroke during the study. This will allow us to explore the relationship between increased VVV and incident stroke in a more robust manner. The results may help improve secondary stroke prevention for patients with recent noncardioembolic ischemic stroke, who comprise >50% of the annual strokes in the United States. The aim of our study is to determine if the effect of increased blood pressure VVV is linked to the development of stroke in patients enrolled in the PRoFESS trial. To answer this question, we will analyze the PRoFESS data to compare the amount of VVV in patients with or without stroke. This is called a retrospective study, which is not the preferred method to answer this question, but the data in the PRofESS trial is of such high quality that it is an acceptable tradeoff. We will publish our findings in a major academic journal and also have the public relations department at the University of Utah release a press briefing when it is published.
Study Data Provided
[{ "PostingID": 1970, "Title": "BI-9.159", "Description": "PRoFESS - Prevention Regimen For Effectively Avoiding Second Strokes" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
The publication citation will be added after the research is published.
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