Follow-up of Patients Bound for PCI After Implementation of a Helicopter Emergency Medical System
Helicopter Versus Ground Emergency Medical Systems and the Effect on Mortality and Labour Market Affiliation of Patients Bound for Percutaneous Coronary Intervention
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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).
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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).
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May 1st 2010, the first Danish Helicopter Emergency Medical System (HEMS) was implemented in Region Zealand and the Capital Region of Denmark.
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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).
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Short term mortality after admission to the PCI unit
時間枠：30 day mortality
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30 day mortality
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Long-term mortality after admission to the PCI unit.
時間枠：Mortality up to 5.5 years after admission to the PCI-unit
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Mortality up to 5.5 years after admission to the PCI-unit
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1-year mortality after admission to the PCI unit.
時間枠：1-year mortality
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1-year mortality
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Time to involuntary early retirement or death from any cause
時間枠：Up to 5.5 years after admission to the PCI unit
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Up to 5.5 years after admission to the PCI unit
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Reduced work ability two years after the coronary event (yes/no).
時間枠：Two years after admission to the PCI unit
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Two years after admission to the PCI unit
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Time on social transfer payments during the first two years after the coronary event
時間枠：Two years after admission to the PCI unit
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Two years after admission to the PCI unit
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Time to involuntary early retirement
時間枠：Up to 5.5 years after admission to the PCI unit
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Up to 5.5 years after admission to the PCI unit
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Kamilia Funder, MD、Department of Anaesthesia, HOC 4231, Rigshospitalet
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Helicopter Emergency Medical Serviceの臨床試験
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University Hospital Heidelbergわからない
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University Hospital Heidelberg完了