Myocardial InfarctionNCT00497419
Reperfusion Time in ST Segment Elevation Myocardial Infarction (STEMI)
A study testing fast track in people with Myocardial Infarction, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Reperfusion delay in STEMI has been shown to be excessive in our community. In order to improve delay a fast track (direct transfer in catheterization laboratory) has been implemented. The present study aims at evaluating the benefits of this procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- fast track
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2007to Oct 2007
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of STEMI
Who cannot join
- On site resuscitated patients
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospital, Emergency Service
Geneva, Canton of Geneva, 1211
About this study
Official title: Evaluation of a Fast Track for Patients With STEMI
Reperfusion delay in STEMI has been shown to be excessive in our community. In order to improve delay a fast track (direct transfer in catheterization laboratory) has been implemented. The present study aims at evaluating the benefits of this procedure.
Read the detailed description
Reperfusion delay in STEMI has been shown to be excessive in our community. Admission in emergency room and waiting for transfer to catheterization laboratory seems to be the principal source of delay. In order to improve delays a fast track (direct transfer in catheterization laboratory) has been implemented for patients being diagnosed with STEMI by emergency physician out of hospital. The present study aims at evaluating the benefits of this procedure.
- Conditions
- Myocardial Infarction
- Being tested
- fast track
- Keywords
- STEMI, ST elevation myocardial infarction
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast trackProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Door to balloon time
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJan 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Olivier Grosgurin, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497419
- Sponsor's protocol ID
- 06199
- Status last verified
- Aug 2008
- First submitted
- 5 Jul 2007
- Last updated
- 20 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grosgurin O, Plojoux J, Keller PF, Niquille M, N'koulou R, Mach F, Sarasin FP, Rutschmann OT. Prehospital emergency physician activation of interventional cardiology team reduces door-to-balloon time in ST-elevation myocardial infarction. Swiss Med Wkly. 2010 Apr 17;140(15-16):228-32. doi: 10.4414/smw.2010.12927.
PubMed 20131111
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Fast Track for Patients With STEMI
- ClinicalTrials.gov ID
- NCT00497419
- Acronym / sponsor ID
- 06199
- Conditions
- Myocardial Infarction
- Keywords
- STEMI, ST elevation myocardial infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Jul 2007 (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.
Reperfusion delay in STEMI has been shown to be excessive in our community. In order to improve delay a fast track (direct transfer in catheterization laboratory) has been implemented. The present study aims at evaluating the benefits of this procedure.
Detailed description
Reperfusion delay in STEMI has been shown to be excessive in our community. Admission in emergency room and waiting for transfer to catheterization laboratory seems to be the principal source of delay. In order to improve delays a fast track (direct transfer in catheterization laboratory) has been implemented for patients being diagnosed with STEMI by emergency physician out of hospital. The present study aims at evaluating the benefits of this procedure.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of STEMI
Key exclusion criteria (1 listed)
- On site resuscitated patients
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 |
|---|---|---|
| fast track | Procedure or surgery | – |
Primary outcome
Door to balloon time
Time frame: one year
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 20 Aug 2008.
- Derived from this study: PubMed 20131111Grosgurin O, Plojoux J, Keller PF, Niquille M, N'koulou R, Mach F, Sarasin FP, Rutschmann OT. Prehospital emergency physician activation of interventional cardiology team reduces door-to-balloon time in ST-elevation myocardial infarction. Swiss Med Wkly. 2010 Apr 17;140(15-16):228-32. doi: 10.4414/smw.2010.12927.
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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.
Olivier Grosgurin, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fast track in people with Myocardial Infarction, run by University Hospital, Geneva at 1 site in Switzerland.
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 20 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Door to balloon time (time frame: one year). 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 NCT00497419, which also lists 1 linked publication.
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 20 Aug 2008.