- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322786
The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective?
November 11, 2020 updated by: University College, London
The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective? An Analysis Using UK Based Electronic Health Records of 5.6 Million Individuals.
The study use UK based linked electronic health records from the Clinical Research Datalink (CALIBER) of 5.6 million individuals to conduct a matched case-control study to investigate the incidence of influenza in individuals prescribed ACEI compared to those not prescribed ACEI.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1302508
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
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The nested case-control study include cases who had an ACEI prescription during study follow-up.
We randomly select one control per case from the study cohort of individuals without any documented ACEI use.
Controls are matched to incident AF patients according to sex, age (10-year age strata).
Description
Inclusion Criteria:
- We identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.
Exclusion Criteria:
- We exclude individuals with a prior history of influenza and viral pneumonia before study entry.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ACEI user
Individuals with an ACEI prescription in the study population.
|
Any prescription of ACE inhibitor
|
|
Matched controls
Individuals without an ACEI prescription, and matched to the users by sex and 10-year age categories.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of influenza
Time Frame: Jan 1st 1998 - May 31st 2016
|
Jan 1st 1998 - May 31st 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 1998
Primary Completion (Actual)
May 31, 2016
Study Completion (Anticipated)
March 31, 2021
Study Registration Dates
First Submitted
March 23, 2020
First Submitted That Met QC Criteria
March 23, 2020
First Posted (Actual)
March 26, 2020
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 11, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISAC17_205R
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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