ST-elevation Myocardial InfarctionNCT02512991
Follow-up of Patients Bound for PCI After Implementation of a Helicopter Emergency Medical System
An observational study of ST-elevation Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- Helicopter Emergency Medical Service
- How many people
- 1,604 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Helicopter Versus Ground Emergency Medical Systems and the Effect on Mortality and Labour Market Affiliation of Patients Bound for Percutaneous Coronary Intervention
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.
Read the detailed 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.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- Helicopter Emergency Medical Service
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicopter Emergency Medical ServiceOther
May 1st 2010, the first Danish Helicopter Emergency Medical System (HEMS) was implemented in Region Zealand and the Capital Region of Denmark.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Helicopter Emergency Medical Service | |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term mortality after admission to the PCI unit
Measured: 30 day mortality
Secondary outcomes (6)
Long-term mortality after admission to the PCI unit.
Measured: Mortality up to 5.5 years after admission to the PCI-unit
1-year mortality after admission to the PCI unit.
Measured: 1-year mortality
Time to involuntary early retirement or death from any cause
Measured: Up to 5.5 years after admission to the PCI unit
Reduced work ability two years after the coronary event (yes/no).
Measured: Two years after admission to the PCI unit
Time on social transfer payments during the first two years after the coronary event
Measured: Two years after admission to the PCI unit
Time to involuntary early retirement
Measured: Up to 5.5 years after admission to the PCI unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startJan 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Kamilia S. Funder, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kamilia Funder, MD, Principal investigator, Department of Anaesthesia, HOC 4231, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512991
- Sponsor's protocol ID
- ALH2-KF-2015
- Status last verified
- Jul 2016
- First submitted
- 27 Jul 2015
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23965353Laut 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.
PubMed 25438906Andersen 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.
PubMed 12930925
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicopter Versus Ground Emergency Medical Systems and the Effect on Mortality and Labour Market Affiliation of Patients Bound for Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02512991
- Acronym / sponsor ID
- ALH2-KF-2015
- Conditions
- ST-elevation Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,604 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Jan 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEMS patients | – | Other: Helicopter Emergency Medical ServicePatients 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). |
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helicopter Emergency Medical ServiceMay 1st 2010, the first Danish Helicopter Emergency Medical System (HEMS) was implemented in Region Zealand and the Capital Region of Denmark. | Other | HEMS patients |
Primary outcome
Short term mortality after admission to the PCI unit
Time frame: 30 day mortality
6 secondary outcomes
Long-term mortality after admission to the PCI unit.
Time frame: Mortality up to 5.5 years after admission to the PCI-unit
1-year mortality after admission to the PCI unit.
Time frame: 1-year mortality
Time to involuntary early retirement or death from any cause
Time frame: Up to 5.5 years after admission to the PCI unit
Reduced work ability two years after the coronary event (yes/no).
Time frame: Two years after admission to the PCI unit
Time on social transfer payments during the first two years after the coronary event
Time frame: Two years after admission to the PCI unit
Time to involuntary early retirement
Time frame: Up to 5.5 years after admission to the PCI unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Background: PubMed 23965353Hesselfeldt 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.
- Background: PubMed 25438906Laut 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.
- Background: PubMed 12930925Andersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamilia Funder, MD principal investigator
Department of Anaesthesia, HOC 4231, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of ST-elevation Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term mortality after admission to the PCI unit (time frame: 30 day mortality). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512991, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.