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Completed

NCT Number: NCT02512991

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

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.

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Key information

Conditions

ST-elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Helicopter Emergency Medical Service

Other

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

Primary outcomes

  1. Short term mortality after admission to the PCI unit

    Time frame: 30 day mortality

Secondary outcomes

  1. Long-term mortality after admission to the PCI unit.

    Time frame: Mortality up to 5.5 years after admission to the PCI-unit

  2. 1-year mortality after admission to the PCI unit.

    Time frame: 1-year mortality

  3. Time to involuntary early retirement or death from any cause

    Time frame: Up to 5.5 years after admission to the PCI unit

  4. Reduced work ability two years after the coronary event (yes/no).

    Time frame: Two years after admission to the PCI unit

  5. Time on social transfer payments during the first two years after the coronary event

    Time frame: Two years after admission to the PCI unit

  6. Time to involuntary early retirement

    Time frame: Up to 5.5 years after admission to the PCI unit

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • TrygFonden, Denmark

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2015
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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