Pre-hospital triage in patients with low risk of NSTE-ACS will reveal a large saving in health care resources in favor of the pre-hospital rule strategy with additional GP management. At 12 months the strategy will corroborate with a very low event…
ID
Bron
Verkorte titel
Aandoening
chest pain, myocardial infarction, non-ST segment elevation acute coronary syndrome, troponin
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint consists of a significant reduction in health care costs at 30 days by a decrease in health care resources and use of ambulance
Achtergrond van het onderzoek
Of all patients suspected of non ST-segment elevation acute coronaire syndrome (NSTE-ACS), the majority is currently presented at the hospital emergency departments (ER) to rule out NSTE-ACS. In patients with a low risk profile for ACS, NSTE-ACS is however rarely found. All these presentations on the other hand contribute to an overcrowded ER, increase of patient transfers by ambulance services and a problematic increase in health care costs.
Recent studies have suggested that by using a simple rule-out strategy including a risk algorithm and a point-of-care (POC) troponin device, ambulance personnel can discriminate between high and low risk of NSTE-ACS. In the latter, adequate pre-hospital risk stratification may prevent unnecessary ER presentations and consequently reduce costs. The HEART (History, ECG, Age, Risk factors and Troponin) risk score is a simple validated risk tool which can facilitate risk stratification and decision making on the spot. Low risk chest pain patients can easily be identified and early discharged from the ER with very low risk of major adverse cardiac events (MACE). With regard to its friendly near the patient use and fast turn-around-time, POC troponin devices have increasingly gained popularity and its application is ideal for use in the pre-hospital setting.
Research quastion: to assess the cost-effectiveness and efficacy of ambulance triage with further general practitioner management versus standard hospital admission in patients with symptoms suggestive for NSTE-ACS, but with very low risk (HEART score equal or less than 3, POC troponin below the upper referernce limit.
Doel van het onderzoek
Pre-hospital triage in patients with low risk of NSTE-ACS will reveal a large saving in health care resources in favor of the pre-hospital rule strategy with additional GP management. At 12 months the strategy will corroborate with a very low event rate (MACE rate < 1.5%)
Onderzoeksopzet
1 month: health care costs: cost per gained quality adjusted life years (QUALY), iMTA PCQ, friction cost-method, quality of health (EuroQol-5D-5L)
1 month: death, acute coronary syndrome, stroke
6 months: death, acute coronary syndrome, stroke
12 months: death, acute coronary syndrome, stroke. Health care costs
Onderzoeksproduct en/of interventie
Pre-hospital triage with management by the General practitioner versus pre-hospital triage with standard referral to the hospital
Publiek
Cyril Camaro
P.O. Box 9101, 6500 HB
Nijmegen
The Netherlands
+31 24 361 45 33
cyril.camaro@radboudumc.nl
Wetenschappelijk
Cyril Camaro
P.O. Box 9101, 6500 HB
Nijmegen
The Netherlands
+31 24 361 45 33
cyril.camaro@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age at least 18 years; male ánd female
- All out-of-hospital patients with chest pain or symptoms suggestive of ACS initially visited by an ambulance with an indication for transfer to a hospital to evaluate and rule out ACS
- Symptom duration for at least two hours
- Modified HEAR(T) score less or equal than 3
- A point of care troponin below the upper reference limit (for patients stratified to prehospital management by the general practitioner)
- The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Electrocardiographic ST-segment elevation
- Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.
- Patients in comatose state, defined as an EMV <8
- Patients with known cognitive impairment
- Pregnancy or intention to become pregnant during the course of the study
- 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 syncope
- Patients presenting with signs of heart failure
- Patients presenting with heart rhythm disorders and second or third degree atrioventricular block
- Patients with known end-stage renal disease (dialysis and/or MDRD < 30 ml/min)
- Patients without a pre-hospital 12-lead ECG performed or available
- Patients suspicious of aortic dissection or pulmonary embolism
- Patients with confirmed AMI, PCI or CABG <30 days prior to inclusion
- Communication issues with patient/language barrier
- Decision of a present general practitioner to evaluate the patient at ER
- Decision of the consultant cardiologist to evaluate patient at the ER irrespective of HEART score
- Any significant medical or mental condition, which in the Investigator¡¯s opinion may interfere with the patient¡¯s optimal participation in the study
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7148 |
| NTR-old | NTR7346 |
| Ander register | METC Arnhem-Nijmegen : 2018-4676 |