Myocardial InfarctionNCT00632788
The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time
An observational study of Myocardial Infarction, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
This study was designed to investigate the influence of the acute myocardial infarction checklist on the door-to-balloon time in patients suffering from acute STEMI at Far Eastern Memorial Hospital 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?
- acute myocardial infarction checklist
- How many people
- 213 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2006to Dec 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with diagnostic criteria of acute ST-elevation myocardial infarction who were preparing for emergency cardiac catheterization
Who may be able to join
- all patients who presented to the emergency department of Far Eastern Memorial Hospital within 12 hours of the onset of ischemic chest pain
- patients with diagnostic criteria of acute ST-elevation myocardial infarction on electrocardiogram, e.g. at least 0.1 mV in two or more contiguous electrocardiographic leads or a new onset of bundle branch block
- patients were preparing for emergency cardiac catheterization
Who cannot join
- patients who did not fulfill the diagnostic criteria of acute myocardial infarction on electrocardiogram
- patients who were not eligible for cardiac catheterization
- patients who refused cardiac catheterization
- patients who suffered from acute myocardial infarction after admission to ward or intensive care unit for any reason
- patients who had an ambiguous diagnosis that the decision of emergency cardiac catheterization was made after admission to ward or intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time in Patients Suffering From Acute ST-Elevation Myocardial Infarction
This study was designed to investigate the influence of the acute myocardial infarction checklist on the door-to-balloon time in patients suffering from acute STEMI at Far Eastern Memorial Hospital
- Conditions
- Myocardial Infarction
- Being tested
- acute myocardial infarction checklist
- Keywords
- myocardial infarction, catheterization, angioplasty, door-to-balloon time
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute myocardial infarction checklistOther
For every patient fulfilling the criteria of enrollment, an acute myocardial infarction checklist was incorporated into the patient's medical records at emergency department immediately after a diagnosis of acute ST-elevation myocardial infarction was made. All the time sequences concerning different managements at different locations were recorded by nurses and/or physicians as instructions on the checklist.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | patients presented with acute ST-elevation myocardial infarction and received emergency cardiac catheterization between March 1, 2007 and Oct. 31, 2007 Receives: Other: acute myocardial infarction checklist | |
| control group | patients presented with acute ST-elevation myocardial infarction and received emergency cardiac catheterization between April 1, 2006 and Feb. 28, 2007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
median door-to-balloon time
Measured: at cath. lab
Secondary outcomes (1)
in-hospital mortality
Measured: at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startApr 2006
- Primary completionOct 2007
- Study completionDec 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chao-Lun Lai, M.D., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632788
- Sponsor's protocol ID
- 97005
- Status last verified
- Jan 2008
- First submitted
- 3 Mar 2008
- Last updated
- 11 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lai CL, Fan CM, Liao PC, Tsai KC, Yang CY, Chu SH, Chien KL. Impact of an audit program and other factors on door-to-balloon times in acute ST-elevation myocardial infarction patients destined for primary coronary intervention. Acad Emerg Med. 2009 Apr;16(4):333-42. doi: 10.1111/j.1553-2712.2009.00372.x.
PubMed 19456296
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Acute Myocardial Infarction Checklist on the Door-to-Balloon Time in Patients Suffering From Acute ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00632788
- Acronym / sponsor ID
- 97005
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, catheterization, angioplasty, door-to-balloon time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Mar 2008 (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 was designed to investigate the influence of the acute myocardial infarction checklist on the door-to-balloon time in patients suffering from acute STEMI at Far Eastern Memorial Hospital
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Other: acute myocardial infarction checklistpatients presented with acute ST-elevation myocardial infarction and received emergency cardiac catheterization between March 1, 2007 and Oct. 31, 2007 |
| control group | – | –patients presented with acute ST-elevation myocardial infarction and received emergency cardiac catheterization between April 1, 2006 and Feb. 28, 2007 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with diagnostic criteria of acute ST-elevation myocardial infarction who were preparing for emergency cardiac catheterization
Key inclusion criteria (3 listed)
- all patients who presented to the emergency department of Far Eastern Memorial Hospital within 12 hours of the onset of ischemic chest pain
- patients with diagnostic criteria of acute ST-elevation myocardial infarction on electrocardiogram, e.g. at least 0.1 mV in two or more contiguous electrocardiographic leads or a new onset of bundle branch block
- patients were preparing for emergency cardiac catheterization
Key exclusion criteria (5 listed)
- patients who did not fulfill the diagnostic criteria of acute myocardial infarction on electrocardiogram
- patients who were not eligible for cardiac catheterization
- patients who refused cardiac catheterization
- patients who suffered from acute myocardial infarction after admission to ward or intensive care unit for any reason
- patients who had an ambiguous diagnosis that the decision of emergency cardiac catheterization was made after admission to ward or intensive care unit
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 |
|---|---|---|
| acute myocardial infarction checklistFor every patient fulfilling the criteria of enrollment, an acute myocardial infarction checklist was incorporated into the patient's medical records at emergency department immediately after a diagnosis of acute ST-elevation myocardial infarction was made. All the time sequences concerning different managements at different locations were recorded by nurses and/or physicians as instructions on the checklist. | Other | intervention group |
Primary outcome
median door-to-balloon time
Time frame: at cath. lab
1 secondary outcome
in-hospital mortality
Time frame: at hospital discharge
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 Mar 2008.
- Derived from this study: PubMed 19456296Lai CL, Fan CM, Liao PC, Tsai KC, Yang CY, Chu SH, Chien KL. Impact of an audit program and other factors on door-to-balloon times in acute ST-elevation myocardial infarction patients destined for primary coronary intervention. Acad Emerg Med. 2009 Apr;16(4):333-42. doi: 10.1111/j.1553-2712.2009.00372.x.
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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.
Chao-Lun Lai, M.D. principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 Mar 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 Taiwan. 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?
median door-to-balloon time (time frame: at cath. lab). 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 NCT00632788, 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 11 Mar 2008.