Myocardial InfarctionEHARTNCT00800163
Improving Door-to-Balloon Time in STEMI
A study testing ED Activation/Immediate Transfer in people with Myocardial Infarction, run by St. Francis Hospitals & Health Centers at 1 site in United States.
Trial summary
The investigators prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization lab and (2) immediate transfer of the patient to an immediately available catheterization lab by an in-house transfer team consisting of an… 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?
- ED Activation/Immediate Transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2012
- 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
None listed.
Who cannot join
- Patients who are inpatients
- A registry of all patients who undergo emergency cardiac catheterization irrespective of etiology is maintained.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Francis Heart Center
Indianapolis, Indiana, 46259
Umesh N. Khot, M.D., 317-893-1666, khot@cvresearch.net
About this study
Official title: Emergency Department Physician Activation of the Catheterization Laboratory and Immediate Transfer to an Immediately Available Catheterization Lab Reduce Door-to-Balloon Time in ST-Elevation Myocardial Infarction
The investigators prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization lab and (2) immediate transfer of the patient to an immediately available catheterization lab by an in-house transfer team consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse.
Read the detailed description
Please see Circulation. 2007;116:67-76
- Conditions
- Myocardial Infarction
- Being tested
- ED Activation/Immediate Transfer
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED Activation/Immediate TransferOther
ED Physician Activation and Immediate Transfer Protocol - see Circulation. 2007;116:67-76
| Study group | Role | What they receive |
|---|---|---|
| ED Physician Activation/Immediate Transfer | Experimental | Not described Receives: Other: ED Activation/Immediate Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Door-to-Balloon Time
Measured: 24 hours
Secondary outcomes (4)
Infarct Size
Measured: 48 hours
In-Hospital Mortality
Measured: ~ 7 days (during index hospitalization)
Hospital Length of Stay
Measured: ~2-7 days (during index hospitalization)
Hospital Costs
Measured: ~2-7 days (during Index Hospitalization) and One Year Followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startSep 2005
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Francis Hospitals & Health Centers
- Sponsor type
- University, hospital or other
- Investigators
- Umesh N Khot, M.D., Principal investigator, Indiana Heart Physicians/St. Francis Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800163
- Sponsor's protocol ID
- St. Francis Heart Center-EHART
- Acronym
- EHART
- Status last verified
- Nov 2008
- First submitted
- 26 Nov 2008
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Khot UN, Johnson ML, Ramsey C, Khot MB, Todd R, Shaikh SR, Berg WJ. Emergency department physician activation of the catheterization laboratory and immediate transfer to an immediately available catheterization laboratory reduce door-to-balloon time in ST-elevation myocardial infarction. Circulation. 2007 Jul 3;116(1):67-76. doi: 10.1161/CIRCULATIONAHA.106.677401. Epub 2007 Jun 11.
PubMed 17562960Khot UN, Johnson-Wood ML, Geddes JB, Ramsey C, Khot MB, Taillon H, Todd R, Shaikh SR, Berg WJ. Financial impact of reducing door-to-balloon time in ST-elevation myocardial infarction: a single hospital experience. BMC Cardiovasc Disord. 2009 Jul 26;9:32. doi: 10.1186/1471-2261-9-32.
PubMed 19631001
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Physician Activation of the Catheterization Laboratory and Immediate Transfer to an Immediately Available Catheterization Lab Reduce Door-to-Balloon Time in ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00800163
- Acronym / sponsor ID
- EHART / St. Francis Heart Center-EHART
- Conditions
- Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- St. Francis Hospitals & Health CentersUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 1 Dec 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.
The investigators prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization lab and (2) immediate transfer of the patient to an immediately available catheterization lab by an in-house transfer team consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse.
Detailed description
Please see Circulation. 2007;116:67-76
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED Physician Activation/Immediate Transfer | Experimental | Other: ED Activation/Immediate Transfer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients who are inpatients
- A registry of all patients who undergo emergency cardiac catheterization irrespective of etiology is maintained.
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 |
|---|---|---|
| ED Activation/Immediate TransferED Physician Activation and Immediate Transfer Protocol - see Circulation. 2007;116:67-76 | Other | ED Physician Activation/Immediate Transfer |
Primary outcome
Door-to-Balloon Time
Time frame: 24 hours
4 secondary outcomes
Infarct Size
Time frame: 48 hours
In-Hospital Mortality
Time frame: ~ 7 days (during index hospitalization)
Hospital Length of Stay
Time frame: ~2-7 days (during index hospitalization)
Hospital Costs
Time frame: ~2-7 days (during Index Hospitalization) and One Year Followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
- Results publication: PubMed 17562960Khot UN, Johnson ML, Ramsey C, Khot MB, Todd R, Shaikh SR, Berg WJ. Emergency department physician activation of the catheterization laboratory and immediate transfer to an immediately available catheterization laboratory reduce door-to-balloon time in ST-elevation myocardial infarction. Circulation. 2007 Jul 3;116(1):67-76. doi: 10.1161/CIRCULATIONAHA.106.677401. Epub 2007 Jun 11.
- Derived from this study: PubMed 19631001Khot UN, Johnson-Wood ML, Geddes JB, Ramsey C, Khot MB, Taillon H, Todd R, Shaikh SR, Berg WJ. Financial impact of reducing door-to-balloon time in ST-elevation myocardial infarction: a single hospital experience. BMC Cardiovasc Disord. 2009 Jul 26;9:32. doi: 10.1186/1471-2261-9-32.
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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.
Umesh N Khot, M.D. principal investigator
Indiana Heart Physicians/St. Francis Heart Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED Activation/Immediate Transfer in people with Myocardial Infarction, run by St. Francis Hospitals & Health Centers at 1 site in United States.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jul 2010. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umesh N Khot, M.D. (317-893-1666, khot@cvresearch.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Door-to-Balloon Time (time frame: 24 hours). 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 NCT00800163, which also lists 2 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 23 Jul 2010.