Acute Coronary SyndromeNCT00764205
Randomized Trial of Prehospital Tropin Levels in Acute Coronary Syndrome (ACS)
An observational study of Acute Coronary Syndrome, run by Redmond Fire Department Medic One at 1 site in United States.
Trial summary
This study randomizes patients seen by Redmond Medic One into a control arm and a study arm when they present with acute coronary syndrome and have non-contributory ECG's (i.e.non-STEMI). The control group is treated normally and delivered to the receiving hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2010
- 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: Patients seen and treated by Redmond Fire Department Medic One.
Who may be able to join
- Over years of age
- ACS without ST-segment elevation
- Patient being transported to one of two participating hospitals
Who cannot join
- Less then 18 years of age.
- Post cardiac arrest.
- ACS with ST-segment elevation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Redmond Fire Department Medic One Units
-Mobile Units in King County-, Washington, 98052
About this study
Official title: Randomized Trial of Prehospital Troponin Assessment Using the i-STAT Blood Analyzer
This study randomizes patients seen by Redmond Medic One into a control arm and a study arm when they present with acute coronary syndrome and have non-contributory ECG's (i.e.non-STEMI). The control group is treated normally and delivered to the receiving hospital. The study group is treated normally as well, however troponin measurements are made using an i-STAT blood analyzer prior to hospital arrival. The results are presented to the receiving physician. Door-to-reperfusion time is monitored for both groups.
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, non STEMI, ECG troponin, iSTAT, Acute coronary syndrome without ST-segment elevation
- Medical subject headings
- Acute Coronary Syndrome, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Troponin measured prior to hospital arrival | |
| Control Group | Patients transported to hospital without troponin measurements enroute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease door-to-reperfusion time for patients with non-STEMI's by measuring troponin levels prior to hospital arrival
Measured: 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2009 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Redmond Fire Department Medic One
- Sponsor type
- Other government
- Collaborators
- Medic One Foundation
- Investigators
- James P Jordan, BS, MS, MICP, Principal investigator, Redmond Fire Department Medic One
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764205
- Sponsor's protocol ID
- 20070224
- Status last verified
- Sep 2008
- First submitted
- 30 Sep 2008
- Last updated
- 1 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Prehospital Troponin Assessment Using the i-STAT Blood Analyzer
- ClinicalTrials.gov ID
- NCT00764205
- Acronym / sponsor ID
- 20070224
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, non STEMI, ECG troponin, iSTAT, Acute coronary syndrome without ST-segment elevation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Redmond Fire Department Medic OneOther government
- Collaborators
- Medic One Foundation
- Study start
- Nov 2006
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 1 Oct 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 randomizes patients seen by Redmond Medic One into a control arm and a study arm when they present with acute coronary syndrome and have non-contributory ECG's (i.e.non-STEMI). The control group is treated normally and delivered to the receiving hospital. The study group is treated normally as well, however troponin measurements are made using an i-STAT blood analyzer prior to hospital arrival. The results are presented to the receiving physician. Door-to-reperfusion time is monitored for both groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Troponin measured prior to hospital arrival |
| Control Group | – | –Patients transported to hospital without troponin measurements enroute |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen and treated by Redmond Fire Department Medic One.
Key inclusion criteria (3 listed)
- Over years of age
- ACS without ST-segment elevation
- Patient being transported to one of two participating hospitals
Key exclusion criteria (3 listed)
- Less then 18 years of age.
- Post cardiac arrest.
- ACS with ST-segment elevation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decrease door-to-reperfusion time for patients with non-STEMI's by measuring troponin levels prior to hospital arrival
Time frame: 3-4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2008.
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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.
James P Jordan, BS, MS, MICP principal investigator
Redmond Fire Department Medic One
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 Acute Coronary Syndrome, run by Redmond Fire Department Medic One 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 3 inclusion and 3 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 1 Oct 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 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?
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?
Decrease door-to-reperfusion time for patients with non-STEMI's by measuring troponin levels prior to hospital arrival (time frame: 3-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2008.