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- Essai clinique NCT02512991
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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).
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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).
|
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).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Short term mortality after admission to the PCI unit
Délai: 30 day mortality
|
30 day mortality
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Long-term mortality after admission to the PCI unit.
Délai: Mortality up to 5.5 years after admission to the PCI-unit
|
Mortality up to 5.5 years after admission to the PCI-unit
|
1-year mortality after admission to the PCI unit.
Délai: 1-year mortality
|
1-year mortality
|
Time to involuntary early retirement or death from any cause
Délai: Up to 5.5 years after admission to the PCI unit
|
Up to 5.5 years after admission to the PCI unit
|
Reduced work ability two years after the coronary event (yes/no).
Délai: Two years after admission to the PCI unit
|
Two years after admission to the PCI unit
|
Time on social transfer payments during the first two years after the coronary event
Délai: Two years after admission to the PCI unit
|
Two years after admission to the PCI unit
|
Time to involuntary early retirement
Délai: Up to 5.5 years after admission to the PCI unit
|
Up to 5.5 years after admission to the PCI unit
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kamilia Funder, MD, Department of Anaesthesia, HOC 4231, Rigshospitalet
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ALH2-KF-2015
Informations sur les médicaments et les dispositifs, documents d'étude
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