The overall aim of this study is to investigate whether the HEART score, which has proven to be safe in previous studies, can be implemented on large scale.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the occurrence of MACE at 6 weeks of inclusion in the
total group. MACE includes: myocardial infarction, PCI, CABG, death by all
causes.
Secondary outcome
- The occurrence of MACE at 6 months of inclusion.
- Number of patients that are secondarily referred to the hospital with a HEART
score of <=3 at 6 weeks and 6 months after inclusion.
- Discharge diagnosis of all patient primarily or secondarily referred to the
hospital within 6 months after inclusion.
- Health care costs.
- The number of inter-hospital transfers between PCI and non-PCI centres in
intermediate and high risk patient groups.
- Length of hospital stay.
- Performed diagnostics.
- Cause of death.
- Differences in patient characteristics between the low, intermediate and high
risk groups.
- Quality of life obtained with SF36 questionnaire at 6 months.
Background summary
Of chest pain persons presenting to the emergency department (ED), only 20-30%
have an acute coronary syndrome and at least 50% of persons have a non-cardiac
cause for their complaints. This cause is often harmless and does not require
hospitalization or further investigations. Therefore those persons can be
discharged from the emergency department within hours. To support an efficient
routine practice in chest pain patients presenting to the emergency department
practice, a risk stratifying instrument named the HEART score was developed and
validated by Backus et al., 2013.
In 2012, the first phase of the FAMOUS TRIAGE study was initiated to
develop an appropriate pre-hospital risk stratification tool for chest pain
patients. Later on, the decision was made to further investigate whether the
HEART score can be used as a pre-hospital risk stratification tool instead of
designing a new risk stratification tool. In this first phase, Troponin was
determined in hospital from a pre-hospital collected blood sample.
In January 2016, the second Famous Triage phase was started in which
the pre-hospital HEART score was completely calculated by ambulance nurses
including a point of care (POC) Troponin measurement. Until now all results
show that persons with a HEART score of three or lower can be monitored at home
safely.
The third phase of Famous Triage has not yet been precisely described
in the design paper or METC approved protocol (W13.039) about the first and
second phase of Famous Triage. This protocol is written to present, and attain
approval for, the third phase of Famous Triage. In this phase, pre-hospital
triage takes place in a controlled, standardized way in which low risk patients
will be monitored at home instead of the emergency department. This phase 3
protocol includes a new sample size calculation, explains how patients are
included together with the obtaining of a short informed consent form and
describes how monitoring at home is organized.
Study objective
The overall aim of this study is to investigate whether the HEART score, which
has proven to be safe in previous studies, can be implemented on large scale.
Study design
This is a prospective, non-randomized, interventional multicenter study.
Intervention
Patients with a HEART score of 3 or lower will be observed at home instead of
at the emergency department when they give informed consent.
Study burden and risks
This study comprehends the shift of observation and risk stratification in low
risk patients. There is no expected extra risk or burden for participants.
Moreover, low risk patients might experience benefit by monitoring at home
instead of at the ED.
dr. van Heesweg 2
Zwolle 8025 AB
NL
dr. van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Chest pain persons without ST segment elevation that are visited by an ambulance
Exclusion criteria
- Comatose state
- Cognitive impairment
- Pregnancy
- Shock
- Cardiac asthma
- Sustained ventricular tachyarrhythmia
- Electrocardiographic ST-segment elevation
- Endstage renal disease
- No pre-hospital 12-lead ECG performed or available
- An obvious non-cardiac cause for chest complaints (trauma, pneumothorax, pneumonia, etc.)
- Strong suspicion of aortic dissection or pulmonary embolism
Design
Recruitment
Medical products/devices used
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 | NL60396.075.16 |