Myocardial IschemiaNCT04522583
Increased CRP Concentrations in Patients Admitted to the Emergency Department With Troponin Elevation Aids to Rule Out Coronary Ischemia
An observational study of Myocardial Ischemia, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Diagnosis of Myocardial Ischemia
- How many people
- 15,000 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2020to Mar 2021
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hille Yaffe Medical Center
Hadera, 38100
Simcha R Meisel, MD, MSC, 972-52-3260931, meisel.simcha@gmail.com
Simcha R Meisel, MD,MSC
About this study
Official title: 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.
- Conditions
- Myocardial Ischemia
- Being tested
- Diagnosis of Myocardial Ischemia
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of Myocardial IschemiaDiagnostic test
Discharge diagnosis of myocardial ischemia
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Diagnosis of Myocardial Ischemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the CRP/Troponin ratio
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
Measured: Within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522583
- Sponsor's protocol ID
- 2020-cardiology-1
- Status last verified
- Aug 2020
- First submitted
- 12 Aug 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased C-reactive Protein Concentrations in Patients Admitted to the Emergency Department With Troponin Level Elevations Aids to Rule Out Coronary Ischemia
- ClinicalTrials.gov ID
- NCT04522583
- Acronym / sponsor ID
- 2020-cardiology-1
- Conditions
- Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 21 Aug 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Troponin-positive ED patients | – | Diagnostic Test: Diagnosis of Myocardial IschemiaAll 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of Myocardial IschemiaDischarge diagnosis of myocardial ischemia | Diagnostic test | Troponin-positive ED patients |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simcha R Meisel, MD, MSC (972-52-3260931, meisel.simcha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the CRP/Troponin ratio (time frame: Within 6 months). 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 3 Sep 2020.