The primary objective is to refer patients with chest pain or other symptoms suspect of ACS more accurately and reduce the number of NCCP patients admitted at the cardiac ED.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is referring patients with ACS more promptly to the
cardiac ED and ruling out ACS in patients with NCCP without referral. We aim to
evaluate the percentual reduction of unnecessary referred patients (patients
admitted to the cardiac ED with NCCP) in comparison to our control group.
Secondary outcome
The secondary objectives are:
1. An overview of the baseline characteristics of the study population
including signs and symptoms at inclusion.
2. A comparison of the baseline characteristics, signs, and symptoms in the
intervention versus control group.
3. An overview of the patients in the URGENT 2.0 intervention group with a
modified HEART score 0-3 (low risk) and the cause of chest pain.
4. An overview of the patients in the URGENT 2.0 intervention group with a
modified HEART score >3 (moderate-high risk) and the cause of chest pain.
5. An overview of the patients in the URGENT 2.0 intervention group with a
modified HEART score 0-3 but eventually a cardiac origin for their complaints
(diagnosed at the cardiac ED)
6. Assessment of the diagnostic value of the modified HEART score. Positive
Predictive Value (PPV), sensitivity, specificity and Negative Predictive Value
(NPV) of the modified HEART score for ACS will be calculated.
7. The mortality and major adverse cardiovascular events (MACE) i.e. acute
myocardial infarction, non-elective percutaneous coronary intervention,
coronary artery bypass grafting or all cause death within 30 days after initial
presentation in the intervention group versus control group.
8. Subgroup analyses for patients with diabetes mellitus.
9. Subgroup analyses for gender differences.
10. Subgroup analyses for type of referral (GP vs. triage nurse GPC vs.
self-referral).
11. Clinical accuracy (Positive Predictive value) of POC Hs cTnI assessment
versus HS cTnT at the cardiac ED.
12. To evaluate the possible medical costs reduction in the URGENT 2.0 patients
and comparison with the control group.
13. Time elapsed from arrival EMT at patient*s home to arrival at ED in
intervention group versus control group.
Background summary
This study aims to aid medical workers (like GP's, triage nurses at the GPC and
EMT personnel) in the diagnostic dilemma of chest pain patients. Patients with
acute coronary syndronne (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 with chest pain or other symptoms
suspect of ACS more accurately and reduce the number of NCCP patients admitted
at the cardiac ED.
Study design
This study is a multicenter,randomized controlled trial aiming to reduce the
percentage of NCCP patients admitted to the cardiac ED by performing the HEART
score compared to our control group.
EMT transport is indicated if:
• Triage nurses at the out-of-office hours GPC determine, based on the NTS
criteria, EMT is necessary.
• GPs examined a patient with chest pain at home and considered EMT is
required.
• Patients with chest pain call EMT (by calling 112) themselves.
The triage nurses at the EMT alarm center will determine based upon regular EMT
protocol and medical history whether there is a high suspicion of (STE-)ACS.
They must take into account the (cardiac) history of the patient and occurrence
of cardiac risk factors such as hypertension, hypercholesterolemia, diabetes
mellitus, rheumatic arthritis (and lifestyle / smoking).
In case of high suspicion of (STE-)ACS regular EMT will be arranged by the
triage nurse at the EMT alarm center.
In all other cases the patient is eligible for participating in the trial and
emergency medical personnel will evaluate the patient at home and check the in-
and exclusion criteria. In case the patient is eligible for study participation
and written informed consent is obtained, the patient will be randomised into
(A) the intervention group: analysis by modified HEART score or (B) control
group: regular (ambulance) care.
There will be fifteen regular ambulances and two rapid responders available for
this study, in the regions Venlo/Venray and Roermond.
INTERVENTION GROUP:
In case of a low HEART score (HEART 0-3) patients will not be referred to the
cardiac ED. Depending on results of the rapid responder*s overall evaluation,
including history and physical examination, these patients will be referred to
the general ED, GPC or treated at home.
Patients who are not referred to the cardiac ED after evaluation with the HEART
score (HEART score 0-3) will have a follow-up at the cardiac ED the next
(on-hour) testing availability (at least 4 hours and up to 24 hours after
initial blood testing) with a laboratory high sensitive troponin-T (HS cTnT)
test and a POC high sensitive troponin-I (HS cTnI) test to confirm the rule
out. Patients referred to the cardiac ED after evaluation with the HEART score
(HEART >3) by the rapid responder will receive standard care.
CONTROLE GROUP:
Patients will receive regular (ambulance)care according to the local protocol.
If necessary, the patient will be admitted at the cardiac ED.
Intervention
Modified HEART score evaluation for analysing the risk of acute coronary
syndrome.
Study burden and risks
Patients enrolled within this study, in the intervention group, will receive a
fingerstick blood test and ECG recording by the rapid responder/paramedic and
for follow-up purposes a venous blood test at the cardiac ED at least four
hours after first blood test (and up to 24 hours after).
Patients in the control group will receive regular care.
We may follow-up within a year if we can not obtain the required information
from medical records.
We expect patients with ACS to be referred more accurately and more promptly to
the ED and thus decreased risks. To evaluate the safety of the participant
during the study course a monitor from the Clinical Trial Centre Maastricht
will be involved.
The rapid responder/paramedic is able to get I.V. access and administer
medication in patients with a high modified HEART score while waiting for
regular EMT transport to the cardiac ED. There is a minimal /negligible risk of
delayed care.
Tegelsweg 210
Venlo 5912 BL
NL
Tegelsweg 210
Venlo 5912 BL
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years.
- Chest pain or other complaints suspect of ACS for at least 2 hours where the
GP or emergency medical personnel are in need of further diagnostics or risk
stratification to come to a decision of referral.
- Patients, who have been informed of the nature of the study, agree to its
provisions and have provided written informed consent.
Exclusion criteria
-- Electrocardiographic ST-segment elevation/High suspicion of STE-ACS.
- Suspicion of an acute non-coronary diagnosis e.g. pulmonary embolism,
thoracic aortic dissection or other life-threatening disease.
- Patients presenting cardiogenic shock, defined as: systolic blood pressure
<90mmHg and heart rate >100 and peripheral oxygen saturation <90% (without
oxygen administration)
- Patients presenting with sudden onset heart rhythm disorders and second or
third degree atrioventricular block.
- Patients with confirmed ACS, PCI or CABG <30 days prior to inclusion.
- Impaired consciousness defined as an EMV <8.
- Severe shortness of breath.
- Patients with known end-stage renal disease (dialysis and/or MDRD < 30
ml/min).
- Patients with known cognitive impairment.
- Communication issues with patient/language barrier.
- Patients already participating in an interventional cardiology or
cardiovascular trial.
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 | NL71820.096.19 |