NCT04522583

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 3, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 12, 2020

Last Update Submit

September 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Within 6 months

Study Arms (1)

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).

Diagnostic Test: Diagnosis of Myocardial Ischemia

Interventions

Discharge diagnosis of myocardial ischemia

Troponin-positive ED patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hille Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Simcha R Meisel, MD, MSC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 21, 2020

Study Start

September 1, 2020

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

September 3, 2020

Record last verified: 2020-08

Locations