The primary objective is to refer patients who contact the out-of-hours GP cooperation (GPC) with suspicion of ACS more accurately.The secondary objectives are:1. A registry of all patients referred to the emergency department (ED) with suspected…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study point is a more accurate referral of patients with suspected ACS
to the cardiac ED and thus the concordance of suspected ACS and the actual
diagnosis. The prompt referral of ACS patients will also be assessed through
evaluation of the delays in these patients. Both of these endpoints will be
compared to the baseline registry that has been executed from 1st of September
2015 until 1st of March 2016.
Secondary outcome
The secondary study endpoint is MACE at 1 year follow-up. This is a combined
endpoint of:
1. Mortality
2. Any ischemic cardiac event
a. ST-elevated myocardial infarction
b. Non ST-elevated myocardial infarction
c. (Unstable) angina pectoris
d. Percutaneous coronary intervention
e. Coronary artery bypass graft surgery (CABG)
f. Resuscitation
Background summary
This study aims to aid the general practitioner (GP) in the diagnostic dilemma
of chest pain patients. Patients with acute coronary syndrome (ACS) should be
referred to the hospital promptly, though referring all patients with chest
pain is not feasible, as up to 80% of the patients with chest pain in the
primary care do not have ACS.
Study objective
The primary objective is to refer patients who contact the out-of-hours GP
cooperation (GPC) with suspicion of ACS more accurately.
The secondary objectives are:
1. A registry of all patients referred to the emergency department (ED) with
suspected ACS to assess the appropriateness of referrals, either by EMT, GP or
as self-referrals. This will be compared to the baseline registry performed
from the 1st of September 2015 until the 1st of March 2016. We will include all
patients referred to the hospital, to not miss any patients who have contacted
the GPC and have been referred promptly to the ED.
2. A comparison of patient characteristics, signs and symptoms to the baseline
registry to evaluate the clinical differences between ACS and NCCP patients.
3. A comparison of patients referred promptly after nurse phone triage at the
GPC at baseline (before intervention) and after intervention.
4. A comparison of patients referred to the ED after evaluation by the GP with
the Heart score including ECG and troponin, compared to referral at baseline
without these tests.
5. Analytical comparison of point of care tester troponin tester versus high
sensitive troponin-I (hsT-I) at second evaluation with blood test.
6. The mortality and major adverse cardiovascular events (MACE) at 30 days, 6
months and 1 year.
Study design
This study is a prospective, observational, prevalence-based cohort study
within the standard care of ACS patients.
Study burden and risks
Patients enrolled within this study will receive a fingerstick blood test and
ECG recording at the GPC and for follow-up purposes a fingerstick blood test
and a venous blood test at least four hours after first blood test (and up to
24 hours after). We may follow-up within a year if we can not obtain the
required information from medical records. We expect no adverse events and
there are no expected risks associated with this protocol. We expect patients
with ACS to be referred more accurately and more promptly to the ED and thus
lowering risks.
Tegelseweg 210
Venlo 5912BL
NL
Tegelseweg 210
Venlo 5912BL
NL
Listed location countries
Age
Inclusion criteria
All patients with chest pain or other complaints suspect of acute coronary syndrome can be included in which the GP at the GP cooperation is in need of further diagnostics to come to a decision.
Exclusion criteria
Patients younger than 18 years.
Patients in which a typical history and/or physical examination requires immediate referral; high suspicion of acute coronary syndrome.
Patients in which an acute non-coronary diagnosis is suspected, e.g. pulmonary embolism, thoracic aortic dissection etc.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60045.096.16 |