Myocardial InfarctionRACING-MINCT03634384
Rapid Use of High-sensitive Cardiac Troponin I for ruling-in and Ruling-out of Acute Myocardial Infarction
An observational study of Myocardial Infarction and Chest Pain, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Early rule-in or rule-out of myocardial infarction (MI) is essential in patients presenting to the Emergency Department with chest pain. Recently, the European Society of Cardiology has suggested an accelerated 0h/1h algorithm to rule-in or rule-out MI as a valid alternative to the standard 0h/3h approach. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Chest Pain
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Nov 2016to Dec 2020
- How long will I take part?
- 30 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chest pain suggestive of myocardial infarction admitted to the Emergency Department
Who may be able to join
- Patients over 18 years of age
- Admitted to the Emergency Department
- Chest pain suggestive of myocardial infarction.
Who cannot join
- Patients <18 years of age
- STEMI at admission
- Dialysis
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Randers Regional Hospital
Randers, 8930
Bo Løfgren, Professor, MD, PhD, +45 78420000, bl@clin.au.dk
Bo Løfgren, Professor, MD, PhD
About this study
Early rule-in or rule-out of myocardial infarction (MI) is essential in patients presenting to the Emergency Department with chest pain. Recently, the European Society of Cardiology has suggested an accelerated 0h/1h algorithm to rule-in or rule-out MI as a valid alternative to the standard 0h/3h approach. So far, the 0h/1h algorithm has only been validated for certain high-sensitive Troponin assays. Moreover, it is unknown if MI can be ruled-out by measuring hs-cTn already at 30 minutes (0h/30m) after presentation to the Emergency Department.
This prospective cohort study aims to investigate, if a high-sensitive Troponin assay can rule-in or rule-out MI, when using a 0h/30m and a 0h/1h algorithm. Serial blood samples will be drawn from each patient and used for biomarker analysis. In addition, patients will be asked to complete a detailed questionnaire on chest pain characteristics.
Read the detailed description
Background: Chest pain is a key symptom of acute coronary syndrome (ACS), but can also represent other cardiac and non-cardiac diseases. Rapid identification of ACS in terms of 'rule-in' or 'rule-out' is essential in order to minimize treatment delay and time to discharge. In the absence of ST-segment elevation myocardial infarction (STEMI) at initial ACS evaluation, the European Society of Cardiology guidelines recommend repeated measurements of high-sensitive cardiac troponin (hs-cTn) at presentation (0h) and 3 hours (3h) after presentation to rule-in and rule-out myocardial infarction (MI). An accelerated algorithm for ruling-in and ruling-out MI after 1h (0h/1h algorithm) has recently been suggested by the European Society of Cardiology as a valid alternative to the standard approach. The novel 0h/1h algorithm has only been validated for certain hs-cTn assays. However, routine use of the 0h/1h algorithm is still not widely implemented, as further data on algorithm performance are warranted.
A study of patients undergoing transcoronary ablation of septal hypertrophy, a clinical model of MI, shows that troponin concentrations measured by a hs-cTn assay significantly increase already after 15 minutes. This indicates that it may be possible to evaluate troponin dynamics even earlier than suggested by the 0h/1h algorithm. So far, no large-scale studies have included measurements of hs-cTn at 30m, and no 0h/30m algorithm has been derived. Therefore it is unknown if rule-in and rule-out of MI can be done safely using a 0h/30m algorithm.
Aim: To investigate if a high-sensitive Troponin Assay can rule-in or rule-out MI, when using a 0h/30m and a 0h/1h algorithm.
Patients and methods: This prospective cohort study will include patients presenting to the Emergency Department with chest pain suggestive of ACS. The study is designed to enroll 1.000 patients with complete blood samples (0h, 30m, 1h and 3h).
The expected incidence of MI in our population is inevitably low due to pre-hospital risk-stratification based on point-of-care troponin and electrocardiogram evaluation in the ambulance. Thus, patients with a very high pre-test probability of MI will be admitted to tertiary care centers with cardiac catheterization facilities rather than a regional hospital as in present study. Pilot study calculations estimate an expected prevalence of MI in our study cohort of approximately 7.4%. Assuming a negative predictive value of 99.7% in the rule-out group, a distribution with 7% patients in the rule-in group and 20% assigned to the observational zone (patients who can't be stratified to either the rule-out or the rule-in group), enrolment of at least 500 patients for derivation of the algorithms and at least 500 for the validation of the respective algorithms will provide an acceptable lower boundary of 98.2% of the two-sided 95% confidence interval.
All patients aged ≥18 years referred to the emergency department at Randers Regional Hospital, Randers, Denmark with chest pain and admitted on the suspicion of ACS will be eligible for the study. Patients will be recruited after initial contact with an emergency department nurse when results of an electrocardiogram as well as vital sign parameters (blood pressure, heart rate, peripheral oxygen saturation, respiratory rate and temperature) are available. Patients <18 years of age, with STEMI at admission, in dialysis treatment or pregnant will be excluded.
The study is conducted in accordance with the Declaration of Helsinki. Oral and written consent will be obtained. Patients will be asked for informed consent to have information passed on from the electronic patient journal regarding gender, age, medicine, previous MI and co-morbidity for use in this study only. Patients declining to participate will receive standard treatment.
Serial blood samples will be drawn at 0h (admission), 30m, 1h and 3h. The blood samples will be analyzed using high-sensitive troponin assays. Additional blood will be stored for each time point to establish a research biobank. Troponin values and troponin dynamics will be paired with final diagnosis for each patient. Two independent physicians will adjudicate the patients' final diagnosis based on data from the electronic patient journal (including physical examination, patient history, laboratory results, electrocardiogram, and other examinations). In cases of disagreement, a consensus decision will be reached after a case review. The treating physician will be blinded to test results at 30m and 1h, with the final therapeutic decision being left to the discretion of the attending physician and relying on troponin measurements at 0h and 3h only. All patients will be asked to complete a questionnaire on, e.g., time of chest pain onset and peak, chest pain characteristics (localization, radiation, sensation), additional symptoms at presentation (diaphoresis, nausea, abdominal pain, syncope, dyspnoea, palpitations), height and weight, smoking status and family history of coronary artery disease.
Significance: This study challenges existing time limits for ACS evaluation by investigating the diagnostic value of hs-cTnI measurements at 30m. If our study shows that rule-out of MI can be performed safely at 30m, ACS evaluation can potentially be accelerated even further. Furthermore, our study will provide data on the performance of the 0h/1h algorithm in a Danish patient cohort. If this study demonstrates that the 0h/1h diagnostic algorithm can be used to safely rule-out MI in a patient cohort with a different risk profile, it can contribute to the acceptance of novel accelerated diagnostic approaches and favor global implementation of the 0h/1h algorithm.
- Conditions
- Myocardial Infarction, Chest Pain
- Keywords
- Myocardial Infarction, Chest Pain
- Medical subject headings
- Myocardial Infarction, 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 |
|---|---|---|
| Derivation cohort | We include eligible patients presenting with chest pain suggestive of myocardial infarction to the emergency department (see eligibility). For the primary study patients will be divided into two groups: 500 patients will serve as derivation cohort. | |
| Validation cohort | We include eligible patients presenting with chest pain suggestive of myocardial infarction to the emergency department (see eligibility). For the primary study patients will be divided into two groups: 500 patients will serve as validation cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic performance of the 0h/1h algorithm in terms of ruling-out MI.
The negative predictive value of the 0h/1h algorithm
Measured: 1 hour after admission blood samples
The diagnostic performance of the 0h/30m algorithm in terms of ruling-out MI.
The negative predictive value of the 0h/30m algorithm
Measured: 30 minutes after admission blood samples
Secondary outcomes (2)
Overall diagnostic performance of the 0h/1h algorithm.
The positive predictive value, sensitivity and specificity of the 0h/1h algorithm.
Measured: 1 hour after admission blood samples
Overall diagnostic performance of the 0h/30m algorithm.
The positive predictive value, sensitivity and specificity of the 0h/30m algorithm.
Measured: 30 minutes after admission blood samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start21 Nov 2016
- Primary completion1 Mar 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- 1,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Randers Regional Hospital
- Responsible party
- Principal investigator, Bo Løfgren, Aarhus University Hospital
- Investigators
- Bo Løfgren, Professor, MD, PhD, Study director, Randers Regional HospitalCamilla Bang, MD, Principal investigator, Randers Regional HospitalCamilla Hansen, MD, Principal investigator, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634384
- Sponsor's protocol ID
- 54559
- Acronym
- RACING-MI
- Status last verified
- Dec 2018
- First submitted
- 10 Aug 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohn JK, Cohn PF. Cardiology patient pages. Chest pain. Circulation. 2002 Jul 30;106(5):530-1. doi: 10.1161/01.cir.0000027208.17824.d6. No abstract available.
PubMed 12147530Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
PubMed 26320110Jaeger C, Wildi K, Twerenbold R, Reichlin T, Rubini Gimenez M, Neuhaus JD, Grimm K, Boeddinghaus J, Hillinger P, Nestelberger T, Singeisen H, Gugala M, Pretre G, Puelacher C, Wagener M, Honegger U, Schumacher C, Moreno Weidmann Z, Kreutzinger P, Krivoshei L, Freese M, Stelzig C, Dietsche S, Ernst S, Rentsch K, Osswald S, Mueller C. One-hour rule-in and rule-out of acute myocardial infarction using high-sensitivity cardiac troponin I. Am Heart J. 2016 Jan;171(1):92-102.e1-5. doi: 10.1016/j.ahj.2015.07.022. Epub 2015 Jul 26.
PubMed 26699605Reichlin T, Schindler C, Drexler B, Twerenbold R, Reiter M, Zellweger C, Moehring B, Ziller R, Hoeller R, Rubini Gimenez M, Haaf P, Potocki M, Wildi K, Balmelli C, Freese M, Stelzig C, Freidank H, Osswald S, Mueller C. One-hour rule-out and rule-in of acute myocardial infarction using high-sensitivity cardiac troponin T. Arch Intern Med. 2012 Sep 10;172(16):1211-8. doi: 10.1001/archinternmed.2012.3698.
PubMed 22892889Reichlin T, Twerenbold R, Wildi K, Gimenez MR, Bergsma N, Haaf P, Druey S, Puelacher C, Moehring B, Freese M, Stelzig C, Krivoshei L, Hillinger P, Jager C, Herrmann T, Kreutzinger P, Radosavac M, Weidmann ZM, Pershyna K, Honegger U, Wagener M, Vuillomenet T, Campodarve I, Bingisser R, Miro O, Rentsch K, Bassetti S, Osswald S, Mueller C. Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay. CMAJ. 2015 May 19;187(8):E243-E252. doi: 10.1503/cmaj.141349. Epub 2015 Apr 13.
PubMed 25869867Mueller C, Giannitsis E, Christ M, Ordonez-Llanos J, deFilippi C, McCord J, Body R, Panteghini M, Jernberg T, Plebani M, Verschuren F, French J, Christenson R, Weiser S, Bendig G, Dilba P, Lindahl B; TRAPID-AMI Investigators. Multicenter Evaluation of a 0-Hour/1-Hour Algorithm in the Diagnosis of Myocardial Infarction With High-Sensitivity Cardiac Troponin T. Ann Emerg Med. 2016 Jul;68(1):76-87.e4. doi: 10.1016/j.annemergmed.2015.11.013. Epub 2016 Jan 12.
PubMed 26794254Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members; Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):2354-94. doi: 10.1161/CIR.0000000000000133. Epub 2014 Sep 23. No abstract available.
PubMed 25249586Liebetrau C, Mollmann H, Nef H, Szardien S, Rixe J, Troidl C, Willmer M, Hoffmann J, Weber M, Rolf A, Hamm C. Release kinetics of cardiac biomarkers in patients undergoing transcoronary ablation of septal hypertrophy. Clin Chem. 2012 Jun;58(6):1049-54. doi: 10.1373/clinchem.2011.178129. Epub 2012 Apr 13.
PubMed 22504118Andersen CF, Bang C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. External validation of a high-sensitive troponin I algorithm for rapid evaluation of acute myocardial infarction in a Danish cohort. Eur Heart J Acute Cardiovasc Care. 2021 Dec 6;10(9):1056-1064. doi: 10.1093/ehjacc/zuab062.
PubMed 34423355Andersen CF, Bang C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. Single troponin measurement to rule-out acute myocardial infarction in early presenters. Int J Cardiol. 2021 Oct 15;341:15-21. doi: 10.1016/j.ijcard.2021.08.005. Epub 2021 Aug 13.
PubMed 34391791Bang C, Hansen C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. Rapid use of high-sensitive cardiac troponin I for ruling-in and ruling-out of acute myocardial infarction (RACING-MI): study protocol. Open Heart. 2019 Apr 3;6(1):e000995. doi: 10.1136/openhrt-2018-000995. eCollection 2019.
PubMed 31168384
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Use of High-sensitive Cardiac Troponin I for ruling-in and Ruling-out of Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03634384
- Acronym / sponsor ID
- RACING-MI / 54559
- Conditions
- Myocardial Infarction, Chest Pain
- Keywords
- Myocardial Infarction, Chest Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Randers Regional Hospital
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Aug 2018 (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.
Early rule-in or rule-out of myocardial infarction (MI) is essential in patients presenting to the Emergency Department with chest pain. Recently, the European Society of Cardiology has suggested an accelerated 0h/1h algorithm to rule-in or rule-out MI as a valid alternative to the standard 0h/3h approach. So far, the 0h/1h algorithm has only been validated for certain high-sensitive Troponin assays. Moreover, it is unknown if MI can be ruled-out by measuring hs-cTn already at 30 minutes (0h/30m) after presentation to the Emergency Department.
This prospective cohort study aims to investigate, if a high-sensitive Troponin assay can rule-in or rule-out MI, when using a 0h/30m and a 0h/1h algorithm. Serial blood samples will be drawn from each patient and used for biomarker analysis. In addition, patients will be asked to complete a detailed questionnaire on chest pain characteristics.
Detailed description
Background: Chest pain is a key symptom of acute coronary syndrome (ACS), but can also represent other cardiac and non-cardiac diseases. Rapid identification of ACS in terms of 'rule-in' or 'rule-out' is essential in order to minimize treatment delay and time to discharge. In the absence of ST-segment elevation myocardial infarction (STEMI) at initial ACS evaluation, the European Society of Cardiology guidelines recommend repeated measurements of high-sensitive cardiac troponin (hs-cTn) at presentation (0h) and 3 hours (3h) after presentation to rule-in and rule-out myocardial infarction (MI). An accelerated algorithm for ruling-in and ruling-out MI after 1h (0h/1h algorithm) has recently been suggested by the European Society of Cardiology as a valid alternative to the standard approach. The novel 0h/1h algorithm has only been validated for certain hs-cTn assays. However, routine use of the 0h/1h algorithm is still not widely implemented, as further data on algorithm performance are warranted.
A study of patients undergoing transcoronary ablation of septal hypertrophy, a clinical model of MI, shows that troponin concentrations measured by a hs-cTn assay significantly increase already after 15 minutes. This indicates that it may be possible to evaluate troponin dynamics even earlier than suggested by the 0h/1h algorithm. So far, no large-scale studies have included measurements of hs-cTn at 30m, and no 0h/30m algorithm has been derived. Therefore it is unknown if rule-in and rule-out of MI can be done safely using a 0h/30m algorithm.
Aim: To investigate if a high-sensitive Troponin Assay can rule-in or rule-out MI, when using a 0h/30m and a 0h/1h algorithm.
Patients and methods: This prospective cohort study will include patients presenting to the Emergency Department with chest pain suggestive of ACS. The study is designed to enroll 1.000 patients with complete blood samples (0h, 30m, 1h and 3h).
The expected incidence of MI in our population is inevitably low due to pre-hospital risk-stratification based on point-of-care troponin and electrocardiogram evaluation in the ambulance. Thus, patients with a very high pre-test probability of MI will be admitted to tertiary care centers with cardiac catheterization facilities rather than a regional hospital as in present study. Pilot study calculations estimate an expected prevalence of MI in our study cohort of approximately 7.4%. Assuming a negative predictive value of 99.7% in the rule-out group, a distribution with 7% patients in the rule-in group and 20% assigned to the observational zone (patients who can't be stratified to either the rule-out or the rule-in group), enrolment of at least 500 patients for derivation of the algorithms and at least 500 for the validation of the respective algorithms will provide an acceptable lower boundary of 98.2% of the two-sided 95% confidence interval.
All patients aged ≥18 years referred to the emergency department at Randers Regional Hospital, Randers, Denmark with chest pain and admitted on the suspicion of ACS will be eligible for the study. Patients will be recruited after initial contact with an emergency department nurse when results of an electrocardiogram as well as vital sign parameters (blood pressure, heart rate, peripheral oxygen saturation, respiratory rate and temperature) are available. Patients <18 years of age, with STEMI at admission, in dialysis treatment or pregnant will be excluded.
The study is conducted in accordance with the Declaration of Helsinki. Oral and written consent will be obtained. Patients will be asked for informed consent to have information passed on from the electronic patient journal regarding gender, age, medicine, previous MI and co-morbidity for use in this study only. Patients declining to participate will receive standard treatment.
Serial blood samples will be drawn at 0h (admission), 30m, 1h and 3h. The blood samples will be analyzed using high-sensitive troponin assays. Additional blood will be stored for each time point to establish a research biobank. Troponin values and troponin dynamics will be paired with final diagnosis for each patient. Two independent physicians will adjudicate the patients' final diagnosis based on data from the electronic patient journal (including physical examination, patient history, laboratory results, electrocardiogram, and other examinations). In cases of disagreement, a consensus decision will be reached after a case review. The treating physician will be blinded to test results at 30m and 1h, with the final therapeutic decision being left to the discretion of the attending physician and relying on troponin measurements at 0h and 3h only. All patients will be asked to complete a questionnaire on, e.g., time of chest pain onset and peak, chest pain characteristics (localization, radiation, sensation), additional symptoms at presentation (diaphoresis, nausea, abdominal pain, syncope, dyspnoea, palpitations), height and weight, smoking status and family history of coronary artery disease.
Significance: This study challenges existing time limits for ACS evaluation by investigating the diagnostic value of hs-cTnI measurements at 30m. If our study shows that rule-out of MI can be performed safely at 30m, ACS evaluation can potentially be accelerated even further. Furthermore, our study will provide data on the performance of the 0h/1h algorithm in a Danish patient cohort. If this study demonstrates that the 0h/1h diagnostic algorithm can be used to safely rule-out MI in a patient cohort with a different risk profile, it can contribute to the acceptance of novel accelerated diagnostic approaches and favor global implementation of the 0h/1h algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation cohort | – | –We include eligible patients presenting with chest pain suggestive of myocardial infarction to the emergency department (see eligibility). For the primary study patients will be divided into two groups: 500 patients will serve as derivation cohort. |
| Validation cohort | – | –We include eligible patients presenting with chest pain suggestive of myocardial infarction to the emergency department (see eligibility). For the primary study patients will be divided into two groups: 500 patients will serve as validation cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chest pain suggestive of myocardial infarction admitted to the Emergency Department
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Admitted to the Emergency Department
- Chest pain suggestive of myocardial infarction.
Key exclusion criteria (4 listed)
- Patients <18 years of age
- STEMI at admission
- Dialysis
- Pregnancy.
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
The diagnostic performance of the 0h/1h algorithm in terms of ruling-out MI.
Time frame: 1 hour after admission blood samples
The negative predictive value of the 0h/1h algorithm
The diagnostic performance of the 0h/30m algorithm in terms of ruling-out MI.
Time frame: 30 minutes after admission blood samples
The negative predictive value of the 0h/30m algorithm
2 secondary outcomes
Overall diagnostic performance of the 0h/1h algorithm.
Time frame: 1 hour after admission blood samples
Overall diagnostic performance of the 0h/30m algorithm.
Time frame: 30 minutes after admission blood samples
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Background: PubMed 12147530Cohn JK, Cohn PF. Cardiology patient pages. Chest pain. Circulation. 2002 Jul 30;106(5):530-1. doi: 10.1161/01.cir.0000027208.17824.d6. No abstract available.
- Background: PubMed 26320110Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
- Background: PubMed 26699605Jaeger C, Wildi K, Twerenbold R, Reichlin T, Rubini Gimenez M, Neuhaus JD, Grimm K, Boeddinghaus J, Hillinger P, Nestelberger T, Singeisen H, Gugala M, Pretre G, Puelacher C, Wagener M, Honegger U, Schumacher C, Moreno Weidmann Z, Kreutzinger P, Krivoshei L, Freese M, Stelzig C, Dietsche S, Ernst S, Rentsch K, Osswald S, Mueller C. One-hour rule-in and rule-out of acute myocardial infarction using high-sensitivity cardiac troponin I. Am Heart J. 2016 Jan;171(1):92-102.e1-5. doi: 10.1016/j.ahj.2015.07.022. Epub 2015 Jul 26.
- Background: PubMed 22892889Reichlin T, Schindler C, Drexler B, Twerenbold R, Reiter M, Zellweger C, Moehring B, Ziller R, Hoeller R, Rubini Gimenez M, Haaf P, Potocki M, Wildi K, Balmelli C, Freese M, Stelzig C, Freidank H, Osswald S, Mueller C. One-hour rule-out and rule-in of acute myocardial infarction using high-sensitivity cardiac troponin T. Arch Intern Med. 2012 Sep 10;172(16):1211-8. doi: 10.1001/archinternmed.2012.3698.
- Background: PubMed 25869867Reichlin T, Twerenbold R, Wildi K, Gimenez MR, Bergsma N, Haaf P, Druey S, Puelacher C, Moehring B, Freese M, Stelzig C, Krivoshei L, Hillinger P, Jager C, Herrmann T, Kreutzinger P, Radosavac M, Weidmann ZM, Pershyna K, Honegger U, Wagener M, Vuillomenet T, Campodarve I, Bingisser R, Miro O, Rentsch K, Bassetti S, Osswald S, Mueller C. Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay. CMAJ. 2015 May 19;187(8):E243-E252. doi: 10.1503/cmaj.141349. Epub 2015 Apr 13.
- Background: PubMed 26794254Mueller C, Giannitsis E, Christ M, Ordonez-Llanos J, deFilippi C, McCord J, Body R, Panteghini M, Jernberg T, Plebani M, Verschuren F, French J, Christenson R, Weiser S, Bendig G, Dilba P, Lindahl B; TRAPID-AMI Investigators. Multicenter Evaluation of a 0-Hour/1-Hour Algorithm in the Diagnosis of Myocardial Infarction With High-Sensitivity Cardiac Troponin T. Ann Emerg Med. 2016 Jul;68(1):76-87.e4. doi: 10.1016/j.annemergmed.2015.11.013. Epub 2016 Jan 12.
- Background: PubMed 25249586Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members; Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):2354-94. doi: 10.1161/CIR.0000000000000133. Epub 2014 Sep 23. No abstract available.
- Background: PubMed 22504118Liebetrau C, Mollmann H, Nef H, Szardien S, Rixe J, Troidl C, Willmer M, Hoffmann J, Weber M, Rolf A, Hamm C. Release kinetics of cardiac biomarkers in patients undergoing transcoronary ablation of septal hypertrophy. Clin Chem. 2012 Jun;58(6):1049-54. doi: 10.1373/clinchem.2011.178129. Epub 2012 Apr 13.
- Derived from this study: PubMed 34423355Andersen CF, Bang C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. External validation of a high-sensitive troponin I algorithm for rapid evaluation of acute myocardial infarction in a Danish cohort. Eur Heart J Acute Cardiovasc Care. 2021 Dec 6;10(9):1056-1064. doi: 10.1093/ehjacc/zuab062.
- Derived from this study: PubMed 34391791Andersen CF, Bang C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. Single troponin measurement to rule-out acute myocardial infarction in early presenters. Int J Cardiol. 2021 Oct 15;341:15-21. doi: 10.1016/j.ijcard.2021.08.005. Epub 2021 Aug 13.
- Derived from this study: PubMed 31168384Bang C, Hansen C, Lauridsen KG, Frederiksen CA, Schmidt M, Jensen T, Hornung N, Lofgren B. Rapid use of high-sensitive cardiac troponin I for ruling-in and ruling-out of acute myocardial infarction (RACING-MI): study protocol. Open Heart. 2019 Apr 3;6(1):e000995. doi: 10.1136/openhrt-2018-000995. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Bo Løfgren, Professor, MD, PhD study director
Randers Regional Hospital
Camilla Bang, MD principal investigator
Randers Regional Hospital
Camilla Hansen, MD principal investigator
Randers Regional Hospital
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 Myocardial Infarction and Chest Pain, run by Aarhus University Hospital at 1 site in Denmark.
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 4 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 5 Dec 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 Denmark. 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 Bo Løfgren, Professor, MD, PhD (+4578420000, bl@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic performance of the 0h/1h algorithm in terms of ruling-out MI. (time frame: 1 hour after admission blood samples). The study lists 2 primary outcomes in all. 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 NCT03634384, which also lists 11 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 5 Dec 2018.