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Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol (ESC-TROP)

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ClinicalTrials.gov Identifier: NCT03421873
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
Region Skane
Lund University
Information provided by (Responsible Party):
Ulf Ekelund, Region Skane

Brief Summary:

Chest pain is a common presenting complaint at the Emergency Department (ED). Many of these patients undergo lengthy assessments in the ED or are admitted which contributes to ED and hospital crowding as well as a substantial health care burden. The now commonly used high-sensitivity cardiac troponin assays enable faster rule-out of acute myocardial infarction (AMI). The European Society of Cardiology (ESC) recommend the use of a 0h/1h high-sensitivity cardiac troponin T (hs-cTnT) protocol, but all studies so far have been observational. The safety and effectiveness of the protocol when implemented in routine care is thus unknown.

The aim of this study is to determine the safety and effectiveness of the ESC 0h/1h hs-cTnT protocol, supplemented with clinical assessment and ECG, when implemented in routine care.


Condition or disease Intervention/treatment
Chest Pain Acute Coronary Syndrome Myocardial Infarction Unstable Angina Other: 0h/1h hs-cTnT protocol

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 16000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness and Safety of a Clinical Assessment and 0h/1h Troponin Rule-Out Protocol
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Group/Cohort Intervention/treatment
Intervention (Implementation) group
Chest pain patients enrolled during a 10 month period after a change in routine care, i.e. the implementation of a 0h/1h hs-cTnT protocol
Other: 0h/1h hs-cTnT protocol
Implementation of a 0h/1h hs-cTnT protocol in routine care

Control group
Chest pain patients managed at the 3 intervention EDs during the corresponding 10 months of the previous year (intervention hospitals acting as their own controls) as well as chest pain patients managed during the corresponding before-and-after period at EDs not implementing the protocol (concurrent controls).



Primary Outcome Measures :
  1. AMI and all-cause death [ Time Frame: 30 days from ED presentation ]
    Comparison of the rate of AMI and all-cause death within 30 days from ED presentation in patients discharged from the ED during the intervention period versus the control period (safety)

  2. ED length of stay [ Time Frame: Through discharge from the ED, on average 5 hours after ED presentation ]
    Comparison of ED length of stay in patients discharged from the ED during the intervention period versus the control period (effectiveness)


Secondary Outcome Measures :
  1. Proportion of ED patients discharged [ Time Frame: Through discharge from the ED, on average 5 hours after ED presentation ]
    Comparison of the proportion of patients discharged from the ED during the intervention period versus the control period

  2. Proportion of patients fulfilling 0h/1h hs-cTnT criteria who have undergone objective testing [ Time Frame: 30 days from ED presentation ]
    Proportion of patients fulfilling 0h/1h hs-cTnT criteria (0h hs-cTnT <5 ng/L or a 0h hs-cTnT <12 ng/L with a 1h increase <3 ng/L) who have undergone objective testing (exercise stress test, myocardial perfusion imaging, CT coronary angiography, coronary angiography) within 30 days during the intervention period.

  3. Non-ACS coronary care unit admissions [ Time Frame: Throughout index hospital visit, on average 2 days after ED presentation ]
    Comparison of the proportion of patients without acute coronary syndrome (ACS) admitted to the coronary care unit during the intervention period versus the control period.

  4. Inappropriate coronary angiographies [ Time Frame: Throughout index hospital visit, on average 2 days after ED presentation ]
    Comparison of the proportion of patients who undergo inappropriate coronary angiographies during the intervention period versus the control period

  5. Total hospital length of stay [ Time Frame: Through discharge from the index hospital visit, on average 2 days after ED presentation ]
    Comparison of total hospital length of stay during the intervention period versus the control period.

  6. ED revisits [ Time Frame: 30 days from ED presentation ]
    Comparison of the proportion of patients with 30-day ED revisits during the intervention period versus the control period.

  7. New admissions [ Time Frame: 30 days from ED presentation ]
    Comparison of the proportion of discharged patients with admissions to inpatient care within 30 days during the intervention period versus the control period.

  8. Health care costs [ Time Frame: 30 days from ED presentation ]
    Comparison of health care costs within 30 days during the intervention period versus the control period. These data will be presented in a separate sub-study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All ED patients with a primary complaint of chest pain will be screened for eligibility
Criteria

Inclusion Criteria:

  • ED presentation with a primary complaint of non-traumatic chest pain
  • Age ≥18 years

Exclusion Criteria:

  • A final diagnosis of STEMI during the index visit
  • No hs-cTnT ordered
  • Patient leaving against medical advice
  • No Swedish personal identification number
  • Previous enrollment
  • Unwillingness to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421873


Contacts
Contact: Arash Mokhtari, MD, PhD +4646170000 arash.mokhtari.0561@med.lu.se
Contact: Ulf Ekelund, MD, PhD +464617000 Ulf.Ekelund@med.lu.se

Locations
Sweden
Helsingborg General Hospital Recruiting
Helsingborg, Sweden
Contact: Jakob Lundager-Forberg, MD, PhD    +4642-406 10 00    Jakob.Lundager-Forberg@skane.se   
Kristanstad Central Hospital Recruiting
Kristianstad, Sweden
Contact: Ulf Ekelund, MD, PhD    +4646-171000    ulf.ekelund@med.lu.se   
Skåne University Hospital Recruiting
Lund, Sweden
Contact: Arash Mokhtari, MD, PhD    +4646-171000    arash.mokhtari.0561@med.lu.se   
Skåne University Hospital Recruiting
Malmö, Sweden
Contact: Ardavan Khoshnood, MD, PhD    +4646-171000    ardavan.khoshnood@gmail.com   
Ystad Hospital Recruiting
Ystad, Sweden
Contact: Caroline Hård af Segerstad, MD    +46411-99 50 00    Caroline.HardafSegerstad@skane.se   
Sponsors and Collaborators
Ulf Ekelund
Region Skane
Lund University
Investigators
Principal Investigator: Arash Mokhtari, MD, PhD Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Department of Cardiology, Lund, Sweden
Principal Investigator: Ulf Ekelund, MD, PhD Lund University, Skåne University Hospital, Department of Internal and Emergency Medicine, Lund, Sweden

Responsible Party: Ulf Ekelund, Principal Investigator, Professor of Emergency Medicine, Region Skane
ClinicalTrials.gov Identifier: NCT03421873     History of Changes
Other Study ID Numbers: ESC-TROP20172018
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Chest Pain
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Angina Pectoris