ST Elevation Myocardial InfarctionNCT03740776
The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in STEMI Patients After PCI
An observational study of ST Elevation Myocardial Infarction, run by Dongying Zhang.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Adult, Older adult
Study population: STEMI Patients
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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)
Read the 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.
- Conditions
- ST Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac events
the relationship between reduced eosinophils percentage and in-hospital MACE
Measured: The median time of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Oct 2015
- Primary completion1 Aug 2017
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongying Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongying Zhang, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740776
- Sponsor's protocol ID
- 2018-35
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in Patients With ST-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03740776
- Acronym / sponsor ID
- 2018-35
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dongying ZhangUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- STEMI Patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major adverse cardiac events
Time frame: The median time of 7 days
the relationship between reduced eosinophils percentage and in-hospital MACE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction, run by Dongying Zhang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac events (time frame: The median time of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.