Follow-up of Patients Bound for PCI After Implementation of a Helicopter Emergency Medical System

ST-elevation Myocardial Infarction Clinical Trial

Official title:

Helicopter Versus Ground Emergency Medical Systems and the Effect on Mortality and Labour Market Affiliation of Patients Bound for Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512991
• Other study ID #: ALH2-KF-2015
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: July 8, 2016
• Start date: January 2010
• Est. completion date: May 2015

Study information

• Verified date: July 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1604
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Infarction
• Myocardial Infarction
• ST-elevation Myocardial Infarction

Intervention

Other:
• Helicopter Emergency Medical Service
May 1st 2010, the first Danish Helicopter Emergency Medical System (HEMS) was implemented in Region Zealand and the Capital Region of Denmark.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	TrygFonden, Denmark

References & Publications (3)

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. — View Citation

Hesselfeldt R, Pedersen F, Steinmetz J, Vestergaard L, Simonsen L, Jørgensen 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. — View Citation

Laut KG, Hjort J, Engstrøm T, Jensen LO, Tilsted Hansen HH, Jensen JS, Pedersen F, Jørgensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term mortality after admission to the PCI unit		30 day mortality	No
Secondary	Long-term mortality after admission to the PCI unit.		Mortality up to 5.5 years after admission to the PCI-unit	No
Secondary	1-year mortality after admission to the PCI unit.		1-year mortality	No
Secondary	Time to involuntary early retirement or death from any cause		Up to 5.5 years after admission to the PCI unit	No
Secondary	Reduced work ability two years after the coronary event (yes/no).		Two years after admission to the PCI unit	No
Secondary	Time on social transfer payments during the first two years after the coronary event		Two years after admission to the PCI unit	No
Secondary	Time to involuntary early retirement		Up to 5.5 years after admission to the PCI unit	No