Acute Coronary SyndromeNCT02002546
Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction
An observational study of Acute Coronary Syndrome, run by Chattanooga-Hamilton County Hospital Authority at 1 site in United States.
Trial summary
1. In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I as measured by the i-STAT immunoassay reliably identifies and excludes an acute myocardial infarction. 2. 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
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 4 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients presenting to the Emergency Department with chest pain or similar symptoms, and risk factors for ACS.
Who may be able to join
- Adult patients 18 years of age or older
- Chest pain suspicious for ACS
- Absence of ST-segment elevation AMI (STEMI) or STEMI equivalent on the initial ECG
- Baseline i-STAT troponin less or equal to 1.0 ng/ml
- Enrollment initiated before 2 hour 'delt' troponin value available for review
- Ability and willingness to participate and cooperate with telephone follow-up evaluations
Who cannot join
- ST-elevation or other ECG criteria that results in the diagnosis of AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics
- Patients with chest pain not deemed to warrant cardiac screening
- Blunt chest trauma
- Tachyarrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
- Cardiac Arrest prior to arrival
- Hemodynamically unstable patients
Show all 13Show fewer
- Pulmonary edema requiring CPAP, BIPAP, or mechanical ventilation
- Baseline i-STAT troponin measurement greater than 1.0 ng/ml
- Baseline and 2-hour i-STAT Troponin measurements not obtained
- Patient (or Legal Representative) unable or unwilling to provide written informed consent
- Subject unwilling or unlikely to comply with study procedures, including protocol-specific blood sampling
- Subject unwilling, unable, or deemed unlikely to respond or participate in telephone follow-up
- Vulnerable populations as deemed inappropriate for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Erlanger Baroness Medical Center
Chattanooga, Tennessee, 37403
About this study
- In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I as measured by the i-STAT immunoassay reliably identifies and excludes an acute myocardial infarction.
- In chest pain patients with suspected acute coronary syndrome whose baseline troponin is above the 99th percentile but less than 0.2ng/ml, a 2hr delta Troponin-I as measured by the i-STAT immunoassay accurately discriminates between acute myocardial infarction and non-acute myocardial infarction troponin elevations.
Read the detailed description
Primary Aims: 1) Demonstrate that a 2hr delta troponin as measured by the i-STAT platform can reliably identify and exclude MI on the initial ED evaluation. 2)Demonstrate that a 2hr delta troponin is useful in the discrimination AMI versus non-AMI conditions in patients with low abnormal baseline Troponin-I values.
Secondary Aims: 1) Demonstrate that a positive 2-hr delta troponin-I identifies patients at highest risk for 30 day ACE. 2) Other Secondary aims TBD.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Heart Attack, Myocardial Infarction, Angina, Chest Pain
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Angina Pectoris, Chest Pain
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 |
|---|---|---|
| ED chest pain presenting patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Troponin value over a two hour interval.
Measured: 2 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completion4 Sep 2015
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 only
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chattanooga-Hamilton County Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002546
- Sponsor's protocol ID
- IRB# 13-069
- Status last verified
- Jan 2018
- First submitted
- 2 Dec 2013
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of a 2-hour Delta Troponin-I During the ED Identification and Exclusion of Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02002546
- Acronym / sponsor ID
- IRB# 13-069
- Conditions
- Acute Coronary Syndrome
- Keywords
- Heart Attack, Myocardial Infarction, Angina, Chest Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Chattanooga-Hamilton County Hospital AuthorityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- 4 Sep 2015 (actual)
- First posted
- 6 Dec 2013 (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.
- In chest pain patients with suspected acute coronary syndrome, a 2-hr delta Troponin-I as measured by the i-STAT immunoassay reliably identifies and excludes an acute myocardial infarction.
- In chest pain patients with suspected acute coronary syndrome whose baseline troponin is above the 99th percentile but less than 0.2ng/ml, a 2hr delta Troponin-I as measured by the i-STAT immunoassay accurately discriminates between acute myocardial infarction and non-acute myocardial infarction troponin elevations.
Detailed description
Primary Aims: 1) Demonstrate that a 2hr delta troponin as measured by the i-STAT platform can reliably identify and exclude MI on the initial ED evaluation. 2)Demonstrate that a 2hr delta troponin is useful in the discrimination AMI versus non-AMI conditions in patients with low abnormal baseline Troponin-I values.
Secondary Aims: 1) Demonstrate that a positive 2-hr delta troponin-I identifies patients at highest risk for 30 day ACE. 2) Other Secondary aims TBD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED chest pain presenting patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to the Emergency Department with chest pain or similar symptoms, and risk factors for ACS.
Key inclusion criteria (6 listed)
- Adult patients 18 years of age or older
- Chest pain suspicious for ACS
- Absence of ST-segment elevation AMI (STEMI) or STEMI equivalent on the initial ECG
- Baseline i-STAT troponin less or equal to 1.0 ng/ml
- Enrollment initiated before 2 hour 'delt' troponin value available for review
Key exclusion criteria (13 listed)
- ST-elevation or other ECG criteria that results in the diagnosis of AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics
- Patients with chest pain not deemed to warrant cardiac screening
- Blunt chest trauma
- Tachyarrhythmia (ventricular tachycardia, supraventricular tachycardia, or rapid atrial fibrillation)
- Cardiac Arrest prior to arrival
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
Change in Troponin value over a two hour interval.
Time frame: 2 hours after baseline
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 24 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chattanooga-Hamilton County Hospital Authority 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 6 inclusion and 13 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 24 Jan 2018. 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?
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?
Change in Troponin value over a two hour interval. (time frame: 2 hours after baseline). 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 24 Jan 2018.