- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04522583
Increased CRP Concentrations in Patients Admitted to the Emergency Department With Troponin Elevation Aids to Rule Out Coronary Ischemia
September 2, 2020 updated by: Hillel Yaffe Medical Center
Increased C-reactive Protein Concentrations in Patients Admitted to the Emergency Department With Troponin Level Elevations Aids to Rule Out Coronary Ischemia
The investigators hypothesized that the CRP/troponin ratio measured in patients presenting to the ED with elevated troponin levels could differentiate between patients with cardiac ischemia and those who present due to a systemic inflammatory or infectious disease.
The aim of the study was to determine the necessary CRP/troponin ratio required to rule out cardiac ischemia in a large ED population and determine its impact on long-term prognosis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
15000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hadera, Israel, 38100
- Hille Yaffe medical center
-
-
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 to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients admitted to the ED at the Hillel Yaffe Medical Center, Hadera, during the period 2016-2019 with cTn level higher than the 99th percentile of cTn concentration in the normal population (>0.014 nanogram/milliliter).
Description
Inclusion Criteria:
- All patients admitted to the ED in the period 2016-2019 with cTn level higher than the 99th percentile of cTn concentration in the normal population (>0.014 nanogram/milliliter).
Exclusion Criteria:
- None
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 |
---|---|
Troponin-positive ED patients
All patients admitted to the ED at the Hillel Yaffe Medical Center in Hadera, Israel, in the period 2016-2019 with cTn level higher than the 99th percentile of cTn concentration in the normal population (>0.014 nanogram/milliliter).
|
Discharge diagnosis of myocardial ischemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of the CRP/Troponin ratio
Time Frame: Within 6 months
|
The accuracy of the CRP/Troponin ratio in ruling out of myocardial ischemia according to the diagnosis of ischemia/coronary intervention at discharge analyzed by standard statistical measures
|
Within 6 months
|
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 (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
March 1, 2021
Study Registration Dates
First Submitted
August 12, 2020
First Submitted That Met QC Criteria
August 19, 2020
First Posted (Actual)
August 21, 2020
Study Record Updates
Last Update Posted (Actual)
September 3, 2020
Last Update Submitted That Met QC Criteria
September 2, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-cardiology-1
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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