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Pre-hospitaal (ambulance) uitsluiten van een hartinfarct middels de HEART score bij patiënten met een verdenking op een hartprobleem.


- candidate number15536
- NTR NumberNTR4205
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-okt-2013
- Secondary IDsIsala Zwolle RAV IJsselvecht
- Public TitlePre-hospitaal (ambulance) uitsluiten van een hartinfarct middels de HEART score bij patiënten met een verdenking op een hartprobleem.
- Scientific TitlePre-Hospital Triage in patients with a suspicion of myocardial infarction. Can myocardial infarction be safely ruled out using the HEART score?
- ACRONYMFAMOUS Triage Rule Out
- hypothesisRisk stratifying patients in the pre-hospital phase(ambulance or GP) by using the validated HEART score
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria•All out-of-hospital patients visited by an ambulance and a pre-hospital clinical suspicion of acute myocardial infarction
•Transfer to a hospital
•Age ≥ 18 years
- Exclusion criteria•Comatose state
•Cognitive impairment
•Pregnancy
•(Cardiogenic) shock
•Cardiac asthma
•Sustained ventricular tachyarrhythmia
•End stage renal disease (dialysis patients)
•No pre-hospital 12-lead ECG performed or available
•ST-segment elevation
•An obvious non-cardiac cause for the chest complaints, e.g. trauma, pneumothorax, pneumonia, etc.
•Strong Suspicion of aortic dissection or pulmonary embolism
•New onset left branch bundle block (LBBB)
•Confirmed AMI <10 days prior to inclusion
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 18-jun-2012
- planned closingdate1-jul-2014
- Target number of participants1250
- InterventionsVenous Blood sampling HEART score assessment
- Primary outcome•Percentage of patients with or without infarct diagnosis in the different HEART score categories (0-3, 4-6, >6)
- Secondary outcome•Discharge Diagnosis other than myocardial infarction
•Diagnostics used in ER
•Duration of Hospital Stay (hrs, days)
•Costs
- Timepoints•Discharge from ER/Hospital
•30 day FUP
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. A.W.J. Hof, van 't
- CONTACT for SCIENTIFIC QUERIESMD. PhD. A.W.J. Hof, van 't
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken
- PublicationsN/A
- Brief summaryEen prospectief observationeel onderzoek naar de waarde van de HEART score in de pre-hospitale fase (ambulance) bij patienten met een verdenking op een acuut hartinfarct. Het onderzoek wordt uitgevoerd door ambulancepersoneel in samenwerking met cardiologen van de ziekenhuizen waar patienten naar vervoerd worden. Momenteel zijn dit de regio's Zwolle, Deventer en Amersfoort
- Main changes (audit trail)New intervention: Pre-hospital venous blood sampling and assessment of the modified HEART score.

New brief summary: A prospective observational trial to assess the value of the HEART score in the pre-hospital phase (ambulance) in patients with a clinical suspicion of acute myocardial infarction. The trial is performed in close collaboration with ambulance paramedics. In the area of Zwolle, Deventer and Amersfoort, Ruling-Out low risk patients will be of most interest. In the area of Utrecht, the Rule-In part of the study has started to identify patients at high risk of having acute myocardial infarction. These results will be combined to assess the best cut-off value for triaging patients with a clinical suspicion of cardiac ischemia . A detailed description of the overall FAMOUS TRIAGE project will be ready the beginning of 2014.
- RECORD8-okt-2013 - 3-jan-2014


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