Acute Myocardial InfarctionCONTRASTNCT03214029
COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial
An observational study of Acute Myocardial Infarction and Acute Coronary Syndrome, run by Fred Apple at 1 site in United States.
Trial summary
Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Acute Coronary Syndrome
- What is being tested?
- Cardiac troponin testing
- How many people
- 2,286 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 13 Feb 2026
- 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
- Adult, Older adult
Study population: Consecutive patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.
Who may be able to join
- Adult, defined as subject 18 years of age or older
- Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial cTnI measurement.
- At least one 12-lead electrocardiogram
Who cannot join
- Currently pregnant
- Trauma related admission
- Cardiac arrest
- Decline to participate
- Did not present through the ED
- Transferred from an outside hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Read the detailed description
Background: Comparative studies addressing the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking.
Study objective: Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Null Hypothesis: hs-cTnI and or hs-cTnT assays will offer comparable diagnostic performance for acute myocardial injury and acute myocardial
- Being tested
- Cardiac troponin testing
- Keywords
- troponin, high-sensitivity cardiac troponin, acute myocardial infarction
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac troponin testingDiagnostic test
Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.
| Study group | Role | What they receive |
|---|---|---|
| Study population | Prospective, observational cohort study of consecutives patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction. Receives: Diagnostic Test: Cardiac troponin testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.
Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction
Measured: on admission
Secondary outcomes (6)
All-cause mortality
Any death
Measured: Up to 180-days
Cardiac death
Death due to cardiac reasons.
Measured: Up to 180-days
Unstable angina
Diagnosis of unstable angina per chart review up to 180-days
Measured: Up to 180-days
Acute myocardial infarction
Diagnosis of Acute myocardial infarction per chart review up to 180 days.
Measured: Up to 180-days
Revascularization
Coronary artery bypass graft surgery or percutaneous coronary intervention
Measured: Up to 180-days
Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.
Safety outcome for tested diagnostic strategies will be defined at 30-days, including index hospitalization events for MACE - Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.
Measured: 30-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start6 Nov 2017
- Primary completion31 Dec 2022
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Prospective
- Enrolment
- 2,286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Apple
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diagnostics Division, Hennepin County Medical Center, Minneapolis
- Responsible party
- Sponsor-investigator, Fred Apple, Hennepin Healthcare Research Institute
- Investigators
- Fred S Apple, PhD, Principal investigator, Hennepin County Medical Center and Minneapolis Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214029
- Sponsor's protocol ID
- CONTRAST
- Acronym
- CONTRAST
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2017
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial
- ClinicalTrials.gov ID
- NCT03214029
- Acronym / sponsor ID
- CONTRAST / CONTRAST
- Keywords
- troponin, high-sensitivity cardiac troponin, acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,286 participants (actual)
- Lead sponsor
- Fred AppleUniversity, hospital or other
- Collaborators
- Abbott Diagnostics Division, Hennepin County Medical Center, Minneapolis
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Detailed description
Background: Comparative studies addressing the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking.
Study objective: Compare the analytical and clinical performance of hs-cTnI and hs-cTnT assays for the diagnosis of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.
Null Hypothesis: hs-cTnI and or hs-cTnT assays will offer comparable diagnostic performance for acute myocardial injury and acute myocardial
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Diagnostic Test: Cardiac troponin testingProspective, observational cohort study of consecutives patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients (goal, 2000 patients over 5 months) presenting to the emergency department, in whom serial cTnI measurements are ordered on clinical indication at Hennepin County Medical Center (Minneapolis, MN, USA) to rule-in and rule-out acute myocardial infarction.
Key inclusion criteria (3 listed)
- Adult, defined as subject 18 years of age or older
- Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial cTnI measurement.
- At least one 12-lead electrocardiogram
Key exclusion criteria (6 listed)
- Currently pregnant
- Trauma related admission
- Cardiac arrest
- Decline to participate
- Did not present through the ED
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 |
|---|---|---|
| Cardiac troponin testingFresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays. | Diagnostic test | Study population |
Primary outcome
Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction.
Time frame: on admission
Diagnostic performance of cardiac troponin assays for the diagnosis of acute myocardial injury and myocardial infarction
6 secondary outcomes
All-cause mortality
Time frame: Up to 180-days
Cardiac death
Time frame: Up to 180-days
Unstable angina
Time frame: Up to 180-days
Acute myocardial infarction
Time frame: Up to 180-days
Revascularization
Time frame: Up to 180-days
Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.
Time frame: 30-days
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 15 Oct 2026.
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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.
Fred S Apple, PhD principal investigator
Hennepin County Medical Center and Minneapolis Medical Research Foundation
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 Myocardial Infarction and Acute Coronary Syndrome, run by Fred Apple 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 6 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 15 Oct 2026. 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?
Diagnostic outcome analytical comparison of high-sensitivity cardiac troponin I and T assays for the diagnosis of acute myocardial injury and infarction. (time frame: on admission). 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 15 Oct 2026.