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NCT Number: NCT03214029

COmparisoN of High-sensitivity Cardiac TRoponin I and T ASsays Trial

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myocardial Infarction Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Currently pregnant
  • Trauma related admission
  • Cardiac arrest
  • Decline to participate
  • Did not present through the ED
  • Transferred from an outside hospital

Treatment and study plan

Cardiac Troponin Testing

Diagnostic Test

Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.

Primary outcomes

  1. 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

Secondary outcomes

  1. All-cause mortality

    Time frame: Up to 180-days

    Any death

  2. Cardiac death

    Time frame: Up to 180-days

    Death due to cardiac reasons.

  3. Unstable angina

    Time frame: Up to 180-days

    Diagnosis of unstable angina per chart review up to 180-days

  4. Acute myocardial infarction

    Time frame: Up to 180-days

    Diagnosis of Acute myocardial infarction per chart review up to 180 days.

  5. Revascularization

    Time frame: Up to 180-days

    Coronary artery bypass graft surgery or percutaneous coronary intervention

  6. Safety outcome: Major adverse cardiac events: cardiac death, unstable angina, acute myocardial infarction, revascularization, and congestive heart failure.

    Time frame: 30-days

    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.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • Abbott Diagnostics Division
  • Hennepin County Medical Center, Minneapolis

Registry information

Acronym: CONTRAST

Important dates

Study start
2017
Primary completion
2022
Study completion
2025
First posted
Jul 11, 2017
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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