Implementation of prehospital high Sensitive troponin and risk Stratification- validation phase

Yearly 17.000 patients with acute chest pain are seen by the ambulance service
Rotterdam-Rijnmond, of which approximately 13.500 are presented to the
emergency department (ED). Only a minority of these patients has a serious
condition such as an Acute Coronary Syndrome (ACS). In hospital,
high-sensitivity cardiac troponin (hs-cTn) assays, with or without the use of a
systematic risk score, have extensively improved the diagnosis in patients
suspected of ACS (1,2).
Newly point-of-care (POC) devices for cTnT/I can substantially reduce the
turnaround time for hs-cTn and can be applied earlier in the acute care chain
(3).
Improved triage of acute chest pain patients by use of POC troponin and
systematic risk stratification with a risk score (the HEART score) in the
ambulance might lead to diminished referral to the ED and an increased number
of patients that can be left at home or seen by their general practitioner
(4-7).
This study will be a three phased study assessing the validity, feasibility and
safety of an extended prehospital triage in patients with acute chest pain by
use of a high sensitive POC troponin I, consisting of an analytical validation
of the high sensitive POC troponin, a careful educational program for ambulance
nurses and a before-after intervention study. This phase is the validation
phase

validation Phase objective:
Primary objective is to validate the high sensitive Troponin Quidel Triage True
hsTnI. Secondary objective is to determine the applicability and repeatability.
The focus will be on the ease of use, time spent performing the test.

This study will be a phased study, consisting of before, validation and
implementation.

this phase : Analytical validation of the Quidel Triage True hsTnI,
repeatability and ease of use.

Prospective inclusion of 300 patients prehospital



SPECIAL NOTE:
In order to make sure the study will be performed as careful and safe as
possible, each phase has to be finished and completed before the study can
proceed to the next phase.
After this phase an interim analysis will be performed to ensure that the
Triage True point of care device meets the required validity and ease of use to
be embedded in the workflow of patients with chest pain in the prehospital
setting.

Patients experiencing an episode of acute chest pain will call the emergency
services for help. The dispatcher will send out a call to an ambulance crew.
They will bring the Quidel high sensitive POC troponin I assay. If the patient
meets all the requirements, inclusion will be started. The ambulance nurse
starts by determining the history, EKG, age and risk factor score. During this
time the driver of the ambulance prepares the Quidel troponine array. The
troponine is done after the other scores are known to prevent bias. Troponine
will be determined in every patient 18 years or older with chest pain
suggestive of acute coronary syndrome. Testing for troponine is not required in
patients with obvious cause of non-cardiac chest pain like traumatic injuries,
stabwounds, pulmonary disease, esophageal reflux, panic attacks, or broken ribs
or other. The HEART score divides patients in three categories, Low risk (0-3),
intermediate risk (4-6), and high risk (7-10). Patients with low risk of
developing MACE can be left at home. The ambulance nurse needs to give follow
up advice. Depending on the situation this advice can consist of an appointment
with the general practitioner or to call back when certain symptoms worsen or
persevere. Patients with intermediate risk (4-6) need to be presented at a
nearby emergency department for further evaluation. Patients with high risk
(7-10) should be transported to the nearest hospital capable of percutaneous
coronary intervention and coronary angiography.

There are no extra burden or risks. blood collection through usual care IV and
calculation of HEART-score.