Clinical trial NCT02512991: Follow-up of Patients Bound for PCI After Implementation of a Helicopter Emergency Medical System
Official title: Helicopter Versus Ground Emergency Medical Systems and the Effect on Mortality and Labour Market Affiliation of Patients Bound for Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-elevation Myocardial Infarction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2015-07-31
Enrollment: 1604
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All STEMI patients having acute coronary angiography performed at the PCI centre at Copenhagen University Hospital, Rigshospitalet in a 40-month period from January 1st 2010 until April 30th 2013; and who were diagnosed with STEMI within the geographical area covered by both HEMS and GEMS.

Patients are divided into two groups: 1) "field triaged" (ECG recorded out-of-hospital) and 2) inter-hospital transfers (ECG recorded in-hospital).

Brief summary: This study compares patients bound for Percutaneous Coronary Intervention (PCI) who were transported by either ground ambulance or emergency medical helicopter. The investigators describe long-term follow-up in relation to mortality and labour affiliation.

Detailed description: Since 2003, percutaneous coronary intervention (PCI) for ST-Segment elevation myocardial infarction (STEMI) has been the preferred therapy in Denmark over fibrinolysis (thrombolysis) if performed within 120 minutes. Nevertheless, centralisation of designated PCI-centres may lead to systems delays as transport distance may be longer instead of just choosing thrombolysis at the nearest hospital.

As every minute counts when trying to minimize the ischemic injury and size of infarction following an acute coronary event, timely transportation by helicopter may facilitate overall prognosis.

As a part of a national initiative to improve prehospital care of patients with time critical illness such as myocardial infarction (MI), the first Danish Helicopter Emergency Medical System (HEMS) was implemented in the eastern part of Denmark May 1st 2010.

An initial study on 450 patients investigating short-term effects, found that HEMS significantly reduced time from the first electrocardiogram (ECG) diagnosis on-scene to arrival at the cardiac catheterisation laboratory (CCL) despite longer transport distances. Investigators also found a lower, but insignificant 30-day mortality in HEMS patients, adjusted OR=0.40 (95% CI=0.12-1.39, p=0.14).

The aim of the present study is to investigate long-term effects of HEMS in relation to mortality and labour market affiliation.

Eligibility criteria: Inclusion Criteria:

* The investigators include all STEMI patients having acute coronary angiography performed at the PCI centre at Copenhagen University Hospital, Rigshospitalet in a 40-month period from January 1st 2010 until April 30th 2013; and who were diagnosed with STEMI within the geographical area covered by both HEMS and GEMS. Patients with multiple contacts; only first contact is eligible.

Exclusion Criteria:

* The investigators exclude patients with cardiac arrest before hospital admission. For labour market analyses the investigators exclude patients not working full time three weeks prior to admission.

Primary outcomes:
measure: Short term mortality after admission to the PCI unit
timeFrame: 30 day mortality
Secondary outcomes:
measure: Long-term mortality after admission to the PCI unit.
timeFrame: Mortality up to 5.5 years after admission to the PCI-unit
measure: 1-year mortality after admission to the PCI unit.
timeFrame: 1-year mortality
measure: Time to involuntary early retirement or death from any cause
timeFrame: Up to 5.5 years after admission to the PCI unit
measure: Reduced work ability two years after the coronary event (yes/no).
timeFrame: Two years after admission to the PCI unit
measure: Time on social transfer payments during the first two years after the coronary event
timeFrame: Two years after admission to the PCI unit
measure: Time to involuntary early retirement
timeFrame: Up to 5.5 years after admission to the PCI unit
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesia, HOC 4231, Rigshospitalet
name: Kamilia Funder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hesselfeldt R, Pedersen F, Steinmetz J, Vestergaard L, Simonsen L, Jorgensen E, Clemmensen P, Rasmussen LS. Implementation of a physician-staffed helicopter: impact on time to primary PCI. EuroIntervention. 2013 Aug 22;9(4):477-83. doi: 10.4244/EIJV9I4A77.
citation: Laut KG, Hjort J, Engstrom T, Jensen LO, Tilsted Hansen HH, Jensen JS, Pedersen F, Jorgensen E, Holmvang L, Pedersen AB, Christensen EF, Lippert F, Lang-Jensen T, Jans H, Hansen PA, Trautner S, Kristensen SD, Lassen JF, Lash TL, Clemmensen P, Terkelsen CJ. Impact of health care system delay in patients with ST-elevation myocardial infarction on return to labor market and work retirement. Am J Cardiol. 2014 Dec 15;114(12):1810-6. doi: 10.1016/j.amjcard.2014.09.018. Epub 2014 Sep 28.
citation: Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, Abildgaard U, Pedersen F, Madsen JK, Grande P, Villadsen AB, Krusell LR, Haghfelt T, Lomholt P, Husted SE, Vigholt E, Kjaergard HK, Mortensen LS; DANAMI-2 Investigators. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003 Aug 21;349(8):733-42. doi: 10.1056/NEJMoa025142.