- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03740776
The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in STEMI Patients After PCI
November 13, 2018 updated by: Dongying Zhang
The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in Patients With ST-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
Eosinophils (EOS) in peripheral blood are significantly decreased in ST-segment elevation myocardial infarction (STEMI) and the reduced EOS indicates severe myocardial damage.
Whether EOS is a good predictor for in-hospital major adverse cardiac events (MACEs) of patients with ST-segment elevation myocardial infarction remains unknown.
The aims of this study was to evaluate prognostic role of EOS for in-hospital MACEs in STEMI patients who have undergone primary percutaneous coronary intervention (PCI)
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators retrospectively analyzed the clinical data of 518 patients with STEMI after PCI.
MACEs were defined as cardiac arrest, cardiac rapture, malignant arrhythmia and cardiac death.
The receiver operating characteristic (ROC) curves were used to demonstrate the prognostic value of EOS% in in-hospital MACEs.
All patients were divided into 2 groups according to the best cut-off EOS% value, including reduced EOS% group and control group.
Cox regression analyses and KM survival curve were used to calculate the correlated between EOS with in-hospital MACEs.
Study Type
Observational
Enrollment (Actual)
2
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
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
STEMI Patients
Description
Inclusion Criteria:
- Patients with STEMI who underwent PCI within 12 hours from symptom onset
- Patients from whom informed consent has been properly obtained in writing prior to start of the trial.
Exclusion Criteria:
- Patients with previous myocardial infarction, congenital heart disease
- Patients with liver disease, and renal failure
- Patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
major adverse cardiac events
Time Frame: The median time of 7 days
|
the relationship between reduced eosinophils percentage and in-hospital MACE
|
The median time of 7 days
|
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)
October 1, 2015
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
November 7, 2018
First Submitted That Met QC Criteria
November 13, 2018
First Posted (Actual)
November 14, 2018
Study Record Updates
Last Update Posted (Actual)
November 14, 2018
Last Update Submitted That Met QC Criteria
November 13, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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