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

NCT ID: NCT02512991

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1604 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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ST-elevation Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HEMS patients

Patients bound for Percutaneous Coronary Intervention (PCI) at the PCI centre at Copenhagen University Hospital, Rigshospitalet, and who were transported by Helicopter Emergency Medical Service (HEMS) in a 36-month period (May 1st 2010 - April 30th 2013).

Helicopter Emergency Medical Service

Intervention Type OTHER

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

GEMS patients

Patients bound for Percutaneous Coronary Intervention (PCI) at the PCI centre at Copenhagen University Hospital, Rigshospitalet, and who were transported by Ground Emergency Medical Service in a 40-month period (January 1st 2010 - April 30th 2013).

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TrygFonden, Denmark

INDUSTRY

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kamilia S. Funder

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamilia Funder, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesia, HOC 4231, Rigshospitalet

References

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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.

Reference Type BACKGROUND
PMID: 23965353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25438906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12930925 (View on PubMed)

Other Identifiers

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ALH2-KF-2015

Identifier Type: -

Identifier Source: org_study_id

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