Myocardial InfarctionAROMINCT02666326
Accelerated Rule Out of Myocardial Infarction
A study testing Accelerated, combined biomarker rule-out strategy for MI in people with Myocardial Infarction, run by Aarhus University Hospital Skejby at 3 sites in Denmark.
Trial summary
Every year > 50.000 people in Denmark are hospitalized with a suspected acute myocardial infarction (AMI). The majority has other explanations of their chest discomfort and most are discharged again without any initiation of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Accelerated, combined biomarker rule-out strategy for MI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,516 participants
- Where
- 3 sitesDenmark
- Study dates
- 25 Jan 2016to 3 Sep 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients which, after telemedical triage, are admitted to a cardiac department in suspicions of myocardial infarction
- A peripheral venous catheter has been inserted prehospitally and blood has drawn from it, before flushing it.
Who cannot join
- Age below 18 years
- Patients in which an informed concent can not be obtained (psychiatric disease, dementia, under influence of drugs etc.),
- Suspected STEMI and referral to Primary percutaneous coronary intervention (PPCI), referral to a highly specialized cardiac department for another cardiac reason (e.g ventricular tachycardia, ventricular fibrillation, 3° Atrio-ventricular block.)
- Known central Diabetes insipidus
- Other diagnosis as obvious reason for symptoms at time of admittance (e.g. a new diagnosis of supraventricular tachycardia, pulmonary embolism, aortic dissection) AND no suspicions of ACS
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Cardiology, Aarhus University Hospital
Aarhus, 8200
Department of Internal Medicine, Horsens Regional Hospital
Horsens, 8700
Department of Cardiology, Viborg Regional Hospital
Viborg, Central Jutland, 8800
About this study
Official title: Accelerated Rule-Out of Acute Myocardial Infarction, Using Copeptin and High Sensitive Troponin T - the AROMI Trial
Every year > 50.000 people in Denmark are hospitalized with a suspected acute myocardial infarction (AMI). The majority has other explanations of their chest discomfort and most are discharged again without any initiation of treatment. Still, the suspicion dictates acute ambulance deployment, hospital admission to a highly specialized cardiac unit, cardiac surveillance and cardiac troponin blood sampling. The novel biomarker copeptin, a byproduct of vasopressin production, is released immediately from the pituitary gland as part of the hormonal response to AMI. Peak concentrations are reached within the first hour. Previous studies have suggested the combination of copeptin and cardiac troponin for fast and reliable rule out of AMI. However, the blood sampling should be performed as soon as possible after symptom onset, preferably already during the prehospital phase.
We aim, in an open randomized setting, to investigate the combined measurement of prehospital copeptin and in-hospital high sensitive cardiac Troponin T compared to the standard rule-out procedure of suspected myocardial infarction. We hypothesize that the combined measurement of prehospital copeptin and in-hospital high sensitive troponin T:
- Reduces admission time by 1.5 hours in patients where AMI is ruled out
- Reduces the time to disposition
- Is non-inferior compared to the standard rule-out procedure in relation to major adverse cardiovascular events.
- Is more cost efficient compared to standard diagnostic strategy
Read the detailed description
Patients with suspected Acute Myocardial Infarction (AMI) constitute one of the largest patient groups in emergency medicine. The majority of these patients, however, have other causes than AMI, for their chest discomfort and many are discharged again without any initiation of treatment.(1) At present, cardiac troponin is gold standard in diagnosing AMI. Diagnostic levels of troponin are not reached until hours after onset of symptoms and serial sampling is recommended at intervals of 3-6 hours to confirm or rule-out AMI. The novel biomarker copeptin, a by-product of vasopressin production, is released immediately from the pituitary gland as part of the hormonal response to AMI. However, copeptin elevation, is not specific of AMI. Peak concentrations of copeptin are reached within the first hour and the values normalizes within 4-10 hours.(3) Previous studies have suggested the combination of copeptin and high-sensitive cardiac troponin T (hs-cTnT) for early and reliable rule-out of AMI.(2,3,6) These studies are based on copeptin measurement in blood sample acquired at hospital admission. However, because of the rapid release of copeptin, the blood sampling should be performed as early as possible after symptom onset, preferably already in the ambulance, whereas the analysis can be performed after arrival at the hospital because copeptin is stable. The PREHAB trial conducted in the Central Denmark Region, documented that prehospital blood sampling is performed 70 minutes earlier than first in-hospital sample.(5) Post-trial analysis of blood samples from the PREHAP trial has demonstrated the potential for early and safe rule-out of AMI using the combination of prehospital copeptin and in-hospital troponin analysis. AMI could potentially be safely, ruled out in approximately 40-50% of patients, in whom the AMI diagnosis eventually was dismissed.
During the last 7 years, studies have evaluated the effect and validity of prehospital blood sample analysis. This is now standard procedure in The Central Denmark Region, Denmark.(5) Currently, prehospital blood sampling is carried out in two major randomized studies, aiming at identifying patients with myocardial infarction and heart failure (NCT01638806 and NCT02050282).
Unfortunately, there is at present no point-of-care analysis equipment for copeptin available. Manufacturer of copeptin analysis equipment, Thermo Fischer, has informed that the development of point-care-care equipment is in process, but will not be available in near future. Therefore, we will perform in-hospital analysis of the prehospital blood samples.
Overall aim of this protocol is to demonstrate the combination of troponin T and copeptin as a safe and effective biomarker for rule-out of AMI. In a randomized setting, we will compare the combination of prehospital copeptin and in hospital hs-cTnT, to the standard diagnostic procedure in patients with suspected AMI, evaluating rule-out potential and potential for reduction of the length of stay at the hospital. The diagnostic effects of measuring copeptin/ hs-cTnT in prehospital vs in-hospital blood samples will be evaluated. Moreover an other diagnostic rule-out strategy, using hs-cTNT at admission and 1 hour after admission, will be evaluated in retrospective analysis of blood samples acquired from patients in the conventional diagnostics arm of the study.
Primary purposes of the AROMI trial:
- To evaluate if early discharge, based in the combined biomarker analysis is associated to duration of hospital stay. Will be evaluated in interim analysis after rule out of AMI(discharged within 12 hours) in 900 patients (300 patients in each site)
- To evaluate if early discharge, based in the combined biomarker analysis is associated to major adverse cardiac events (MACE) during index admission, after discharge, within 30, 90, and 365 days of randomization (separately or in combination). No interim evaluation of MACE.
Secondary purposes of the AROMI trial:
- To evaluate if early discharge, based in the combined biomarker analysis is associated to time to decision of discharge or continued hospitalization. Will be evaluated in interim analysis after rule out of AMI(discharged within 12 hours) in 900 patients (300 patients in each site)
- To evaluate if early discharge, based in the combined biomarker analysis is cost-effective regarding satisfaction and safety from a patients perspective.
- To evaluate if early discharge, based in the combined biomarker analysis is cost-effective from a public perspective, regarding staff resources, costs of hospital stay, adherence to the labour market, and use of other healthcare services, Cost benefit analysis(CBA).
- To evaluate if early discharge, based on the hs-cTnT analysis at arrival and 1 hour after arrival at hospital is associated to duration of hospital stay.
- To evaluate if early discharge, based on the hs-cTnT analysis at arrival and 1 hour after arrival at hospital is associated to MACE(major adverse cardiac event) during index admission, after discharge, within 30, 90, and 365 days of randomization (separately or in combination).
- To evaluate the diagnostic properties (including sensitivity, specificity, negative predictive value, and positive predictive value) of the accelerated rule out algorithm using copeptin and high sensitivity troponin. Will be evaluated in interim analysis after rule out of AMI(discharged within 12 hours) in 900 patients (300 patients in each site). Will be evaluated in the total cohort (since both prehospital and inhospital copeptin and high sensitivity troponin is available in all patients) and randomization will not be revealed during this evaluation.
- To evaluate the prognostic value of the accelerated rule out algorithm using copeptin and high sensitivity troponin. Will be evaluated in interim analysis after rule out of AMI(discharged within 12 hours) in 900 patients (300 patients in each site). Will be evaluated in the total cohort (since both prehospital and inhospital copeptin and high sensitivity troponin is available in all patients) and randomization will not be revealed during this evaluation.
- Conditions
- Myocardial Infarction
- Being tested
- Accelerated, combined biomarker rule-out strategy for MI
- Keywords
- Acute Coronary Syndrome, Prehospital emergency care, Biological markers, Copeptin, Troponin, Rule-out, Point-of-Care systems, Infarction, Cardiovascular Diseases, Heart Diseases, Ischemia, Myocardial Ischemia, copeptins, Troponin T, Diagnostic Techniques (Cardiovascular), High sensitivity troponin
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, Diabetes Insipidus, Infarction, Cardiovascular Diseases, Heart Diseases, Ischemia, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated, combined biomarker rule-out strategy for MIProcedure or surgery
Blood sample is acquired while the patient is in the ambulance. This is brought to hospital and handed over to the laboratory personnel for acute analysis for copeptin level. At arrival to hospital, a second blood sample is acquired and analyzed for high-sensitive cardiac troponin-T(hs-cTnT). Answers of these analyzes are in-hand with-in 60 minutes. If copeptin in the pre-hospital blood sample is <9,8 pmol/L (95% percentile) AND hs-cTnT in the in-hospital blood sample is <14ng/L (99% percentile), then myocardial infarction can be ruled out, and depending of clinical presentation, the patient can be discharged.
| Study group | Role | What they receive |
|---|---|---|
| Conventional diagnostic strategy | No intervention | Standard Diagnostics for suspected myocardial infarction, including standard biochemical analysis: min. two measurements of high sensitive troponin T with an interval of minimum 3 hours. A normal value of high sensitive cardiac troponin-T in both blood samples rules out AMI and the patients can be discharged immediately if no other conditions are suspected. |
| Accelerated diagnostic strategy | Experimental | 'Accelerated, combined biomarker rule-out strategy for MI'. Copeptin measurement in a prehospital blood sample combined with high sensitive cardiac troponin T measurement in the first blood sample upon hospital admission, A normal value of both copeptin and cardiac troponin rules out AMI and the patients can be discharged immediately if no other conditions are suspected. Receives: Procedure: Accelerated, combined biomarker rule-out strategy for MI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
Time (hours and minutes) from admission to discharge from cardiac department. Reported by clinical personnel in registration form and supplemented by data from the national health registry. Will be evaluated in interim analysis after inclusion of 300 patients in each site.
Measured: Up to three months from randomization
Combined MACE
Combined endpoint of major adverse cardiac events, consisting of: "All-cause mortality", "survived cardiac arrest", "Confirmed or Readmission with Acute Coronary Syndrome(ACS)", "Non-scheduled coronary intervention", and "Life-threatening arrhythmias" (see below for description) occuring within time from randomization to 30 days after randomization
Measured: Within time from randomization to 30 days after randomization
Secondary outcomes (7)
Time to disposition
Time from admission to decision of early discharge or continued admission for further diagnostics or treatment. Will be evaluated in interim analysis after inclusion of 300 patients in each site.
Measured: Within 24 h of randomization
Combined MACE
Combined endpoint of major adverse cardiac events, consisting of: "All-cause mortality", "survived cardiac arrest", "Readmission with Acute Coronary Syndrome(ACS)", "Non-scheduled coronary intervention", and "Life-threatening arrhythmias" (see below for description)
Measured: Within index admission, within time from discharge to 30, 90, and 365 days after randomization, and within time from randomization to 90 and 365 days after randomization
All-cause mortality
All-cause mortality registered in the national health registry, occurring from time of admission to discharge, within 30, 90 or 365 days after randomization.
Measured: Within index admission and within 30, 90 and 365 days of randomization
Survived, cardiac arrest
Survived cardiac arrest is determined from registration of out-of-hospital cardiac arrest in "Danish register of cardiac arrest" or in-hospital cardiac arrest in "Danarrest" or in the national health registry, occurring from time of admission to discharge, within 30, 90 or 365 days after randomization. The endpoint committee adjudicate survived cardiac arrest, blinded to the initial randomization.
Measured: Within index admission and within 30, 90 and 365 days of randomization
Confirmed diagnosis of ACS or readmission with ACS
The national health registry is used to determine whether the patient is confirmed of having or readmitted with acute coronary syndrome, from time of admission to discharge and within 30, 90 or 365 days after randomization. The endpoint committee adjudicate readmission with acute coronary syndrome, blinded to the initial randomization. The "2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation" and "Universal definition of Myocardial infarction" will be used to evaluate if the patient had: ACS, and subsequently classify it as a: a) Unstable angina pectoris(UAP), b) non-ST-elevation myocardial infarction (NONSTEMI), c) ST-Elevation myocardial infarction (STEMI) d) Bundle branch block myocardial infarction (BBBMI)
Measured: Within index admission and within 30, 90 and 365 days of randomization
Non-scheduled coronary intervention
The national health registry is used to determine whether the patient has non-scheduled re-intervention performed (re-intervention not scheduled at index admission). Time from index admission to first re-intervention and type of re-intervention (PCI or CABG) is determined. The endpoint committee adjudicate re-interventions blinded to original treatment strategy
Measured: Within index admission and within 30, 90 and 365 days of randomization
Life-threatening arrhythmias
The national health registry is used to determine whether the patient is diagnosed or readmitted with a life-threatening arrhythmia, defined as ventricular tachycardia, ventricular fibrillation or third-degree(total) atrioventricular block within index admission and within 30, 90 or 365 days of randomization. The endpoint committee adjudicate readmission with life-threatening arrhythmia, blinded to the initial randomization.
Measured: Within index admission and within 30, 90 and 365 days of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start25 Jan 2016
- Primary completion3 Oct 2019
- Study completion3 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Juhl Terkelsen, Aarhus University Hospital Skejby
- Investigators
- Carsten Stengaard, MD, PhD, Study chair, Aarhus University Hospital SkejbyHanne M Soendergaard, MD, PhD, Study chair, Viborg Regional HospitalChristian J Terkelsen, MD, DmSc, Associate prof., Study chair, Aarhus University Hospital SkejbyKaren K Dodt, MD, PhD, Study chair, Regionshospitalet Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666326
- Sponsor's protocol ID
- AROMI-1
- Acronym
- AROMI
- Status last verified
- Apr 2022
- First submitted
- 24 Jan 2016
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Grande P, H. L. Akut koronar syndrom, retningslinier for diagnostik og behandling. Dansk Cardiologisk Selskab. 2004 Download from http://www.cardio.dk/docman/doc_download/149-akut-koronart-syndrom. (danish)
Maisel A, Mueller C, Neath SX, Christenson RH, Morgenthaler NG, McCord J, Nowak RM, Vilke G, Daniels LB, Hollander JE, Apple FS, Cannon C, Nagurney JT, Schreiber D, deFilippi C, Hogan C, Diercks DB, Stein JC, Headden G, Limkakeng AT Jr, Anand I, Wu AHB, Papassotiriou J, Hartmann O, Ebmeyer S, Clopton P, Jaffe AS, Peacock WF. Copeptin helps in the early detection of patients with acute myocardial infarction: primary results of the CHOPIN trial (Copeptin Helps in the early detection Of Patients with acute myocardial INfarction). J Am Coll Cardiol. 2013 Jul 9;62(2):150-160. doi: 10.1016/j.jacc.2013.04.011. Epub 2013 Apr 30.
PubMed 23643595Morgenthaler NG. Copeptin: a biomarker of cardiovascular and renal function. Congest Heart Fail. 2010 Jul;16 Suppl 1:S37-44. doi: 10.1111/j.1751-7133.2010.00177.x.
PubMed 20653710Reinstadler SJ, Klug G, Feistritzer HJ, Metzler B, Mair J. Copeptin testing in acute myocardial infarction: ready for routine use? Dis Markers. 2015;2015:614145. doi: 10.1155/2015/614145. Epub 2015 Apr 16.
PubMed 25960596Stengaard C, Sorensen JT, Ladefoged SA, Christensen EF, Lassen JF, Botker HE, Terkelsen CJ, Thygesen K. Quantitative point-of-care troponin T measurement for diagnosis and prognosis in patients with a suspected acute myocardial infarction. Am J Cardiol. 2013 Nov 1;112(9):1361-6. doi: 10.1016/j.amjcard.2013.06.026. Epub 2013 Aug 14.
PubMed 23953697Mockel M, Searle J, Hamm C, Slagman A, Blankenberg S, Huber K, Katus H, Liebetrau C, Muller C, Muller R, Peitsmeyer P, von Recum J, Tajsic M, Vollert JO, Giannitsis E. Early discharge using single cardiac troponin and copeptin testing in patients with suspected acute coronary syndrome (ACS): a randomized, controlled clinical process study. Eur Heart J. 2015 Feb 7;36(6):369-76. doi: 10.1093/eurheartj/ehu178. Epub 2014 Apr 30.
PubMed 24786301Pedersen CK, Stengaard C, Botker MT, Sondergaard HM, Dodt KK, Terkelsen CJ. Accelerated -Rule-Out of acute Myocardial Infarction using prehospital copeptin and in-hospital troponin: The AROMI study. Eur Heart J. 2023 Oct 12;44(38):3875-3888. doi: 10.1093/eurheartj/ehad447.
PubMed 37477353Pedersen CK, Stengaard C, Sondergaard H, Dodt KK, Hjort J, Botker MT, Terkelsen CJ. A multicentre, randomized, controlled open-label trial to compare an Accelerated Rule-Out protocol using combined prehospital copeptin and in-hospital high sensitive troponin with standard rule-out in patients suspected of acute Myocardial Infarction - the AROMI trial. Trials. 2018 Dec 12;19(1):683. doi: 10.1186/s13063-018-2990-z.
PubMed 30541594
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Rule-Out of Acute Myocardial Infarction, Using Copeptin and High Sensitive Troponin T - the AROMI Trial
- ClinicalTrials.gov ID
- NCT02666326
- Acronym / sponsor ID
- AROMI / AROMI-1
- Conditions
- Myocardial Infarction
- Keywords
- Acute Coronary Syndrome, Prehospital emergency care, Biological markers, Copeptin, Troponin, Rule-out, Point-of-Care systems, Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,516 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Sep 2020 (actual)
- First posted
- 28 Jan 2016 (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.
Every year > 50.000 people in Denmark are hospitalized with a suspected acute myocardial infarction (AMI). The majority has other explanations of their chest discomfort and most are discharged again without any initiation of treatment. Still, the suspicion dictates acute ambulance deployment, hospital admission to a highly specialized cardiac unit, cardiac surveillance and cardiac troponin blood sampling. The novel biomarker copeptin, a byproduct of vasopressin production, is released immediately from the pituitary gland as part of the hormonal response to AMI. Peak concentrations are reached within the first hour. Previous studies have suggested the combination of copeptin and cardiac troponin for fast and reliable rule out of AMI. However, the blood sampling should be performed as soon as possible after symptom onset, preferably already during the prehospital phase.
We aim, in an open randomized setting, to investigate the combined measurement of prehospital copeptin and in-hospital high sensitive cardiac Troponin T compared to the standard rule-out procedure of suspected myocardial infarction. We hypothesize that the combined measurement of prehospital copeptin and in-hospital high sensitive troponin T:
- Reduces admission time by 1.5 hours in patients where AMI is ruled out
- Reduces the time to disposition
- Is non-inferior compared to the standard rule-out procedure in relation to major adverse cardiovascular events.
- Is more cost efficient compared to standard diagnostic strategy
Detailed description
Patients with suspected Acute Myocardial Infarction (AMI) constitute one of the largest patient groups in emergency medicine. The majority of these patients, however, have other causes than AMI, for their chest discomfort and many are discharged again without any initiation of treatment.(1) At present, cardiac troponin is gold standard in diagnosing AMI. Diagnostic levels of troponin are not reached until hours after onset of symptoms and serial sampling is recommended at intervals of 3-6 hours to confirm or rule-out AMI. The novel biomarker copeptin, a by-product of vasopressin production, is released immediately from the pituitary gland as part of the hormonal response to AMI. However, copeptin elevation, is not specific of AMI. Peak concentrations of copeptin are reached within the first hour and the values normalizes within 4-10 hours.(3) Previous studies have suggested the combination of copeptin and high-sensitive cardiac troponin T (hs-cTnT) for early and reliable rule-out of AMI.(2,3,6) These studies are based on copeptin measurement in blood sample acquired at hospital admission. However, because of the rapid release of copeptin, the blood sampling should be performed as early as possible after symptom onset, preferably already in the ambulance, whereas the analysis can be performed after arrival at the hospital because copeptin is stable. The PREHAB trial conducted in the Central Denmark Region, documented that prehospital blood sampling is performed 70 minutes earlier than first in-hospital sample.(5) Post-trial analysis of blood samples from the PREHAP trial has demonstrated the potential for early and safe rule-out of AMI using the combination of prehospital copeptin and in-hospital troponin analysis. AMI could potentially be safely, ruled out in approximately 40-50% of patients, in whom the AMI diagnosis eventually was dismissed.
During the last 7 years, studies have evaluated the effect and validity of prehospital blood sample analysis. This is now standard procedure in The Central Denmark Region, Denmark.(5) Currently, prehospital blood sampling is carried out in two major randomized studies, aiming at identifying patients with myocardial infarction and heart failure (NCT01638806 and NCT02050282).
Unfortunately, there is at present no point-of-care analysis equipment for copeptin available. Manufacturer of copeptin analysis equipment, Thermo Fischer, has informed that the development of point-care-care equipment is in process, but will not be available in near future. Therefore, we will perform in-hospital analysis of the prehospital blood samples.
Overall aim of this protocol is to demonstrate the combination of troponin T and copeptin as a safe and effective biomarker for rule-out of AMI. In a randomized setting, we will compare the combination of prehospital copeptin and in hospital hs-cTnT, to the standard diagnostic procedure in patients with suspected AMI, evaluating rule-out potential and potential for reduction of the length of stay at the hospital. The diagnostic effects of measuring copeptin/ hs-cTnT in prehospital vs in-hospital blood samples will be evaluated. Moreover an other diagnostic rule-out strategy, using hs-cTNT at admission and 1 hour after admission, will be evaluated in retrospective analysis of blood samples acquired from patients in the conventional diagnostics arm of the study.
Primary purposes of the AROMI trial:
- To evaluate if early discharge, based in the combined biomarker analysis is associated to duration of hospital stay. Will be evaluated in interim analysis after rule out of AMI(discharged within 12 hours) in 900 patients (300 patients in each site)
- To evaluate if early discharge, based in the combined biomarker analysis is associated to major adverse cardiac events (MACE) during index admission, after discharge, within 30, 90, and 365 days of randomization (separately or in combination). No interim evaluation of MACE.
Secondary purposes of the AROMI trial:
- To evaluate if early discharge, based in the combined biomarker analysis is associated to time to decision of discharge or continued hospitalization. Will be evaluated in interim analysis after rule out of AMI(discharged within 12 hours) in 900 patients (300 patients in each site)
- To evaluate if early discharge, based in the combined biomarker analysis is cost-effective regarding satisfaction and safety from a patients perspective.
- To evaluate if early discharge, based in the combined biomarker analysis is cost-effective from a public perspective, regarding staff resources, costs of hospital stay, adherence to the labour market, and use of other healthcare services, Cost benefit analysis(CBA).
- To evaluate if early discharge, based on the hs-cTnT analysis at arrival and 1 hour after arrival at hospital is associated to duration of hospital stay.
- To evaluate if early discharge, based on the hs-cTnT analysis at arrival and 1 hour after arrival at hospital is associated to MACE(major adverse cardiac event) during index admission, after discharge, within 30, 90, and 365 days of randomization (separately or in combination).
- To evaluate the diagnostic properties (including sensitivity, specificity, negative predictive value, and positive predictive value) of the accelerated rule out algorithm using copeptin and high sensitivity troponin. Will be evaluated in interim analysis after rule out of AMI(discharged within 12 hours) in 900 patients (300 patients in each site). Will be evaluated in the total cohort (since both prehospital and inhospital copeptin and high sensitivity troponin is available in all patients) and randomization will not be revealed during this evaluation.
- To evaluate the prognostic value of the accelerated rule out algorithm using copeptin and high sensitivity troponin. Will be evaluated in interim analysis after rule out of AMI(discharged within 12 hours) in 900 patients (300 patients in each site). Will be evaluated in the total cohort (since both prehospital and inhospital copeptin and high sensitivity troponin is available in all patients) and randomization will not be revealed during this evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional diagnostic strategy | No intervention | –Standard Diagnostics for suspected myocardial infarction, including standard biochemical analysis: min. two measurements of high sensitive troponin T with an interval of minimum 3 hours. A normal value of high sensitive cardiac troponin-T in both blood samples rules out AMI and the patients can be discharged immediately if no other conditions are suspected. |
| Accelerated diagnostic strategy | Experimental | Procedure: Accelerated, combined biomarker rule-out strategy for MI'Accelerated, combined biomarker rule-out strategy for MI'. Copeptin measurement in a prehospital blood sample combined with high sensitive cardiac troponin T measurement in the first blood sample upon hospital admission, A normal value of both copeptin and cardiac troponin rules out AMI and the patients can be discharged immediately if no other conditions are suspected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients which, after telemedical triage, are admitted to a cardiac department in suspicions of myocardial infarction
- A peripheral venous catheter has been inserted prehospitally and blood has drawn from it, before flushing it.
Key exclusion criteria (5 listed)
- Age below 18 years
- Patients in which an informed concent can not be obtained (psychiatric disease, dementia, under influence of drugs etc.),
- Suspected STEMI and referral to Primary percutaneous coronary intervention (PPCI), referral to a highly specialized cardiac department for another cardiac reason (e.g ventricular tachycardia, ventricular fibrillation, 3° Atrio-ventricular block.)
- Known central Diabetes insipidus
- Other diagnosis as obvious reason for symptoms at time of admittance (e.g. a new diagnosis of supraventricular tachycardia, pulmonary embolism, aortic dissection) AND no suspicions of ACS
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 |
|---|---|---|
| Accelerated, combined biomarker rule-out strategy for MIBlood sample is acquired while the patient is in the ambulance. This is brought to hospital and handed over to the laboratory personnel for acute analysis for copeptin level. At arrival to hospital, a second blood sample is acquired and analyzed for high-sensitive cardiac troponin-T(hs-cTnT). Answers of these analyzes are in-hand with-in 60 minutes. If copeptin in the pre-hospital blood sample is <9,8 pmol/L (95% percentile) AND hs-cTnT in the in-hospital blood sample is <14ng/L (99% percentile), then myocardial infarction can be ruled out, and depending of clinical presentation, the patient can be discharged. | Procedure or surgery | Accelerated diagnostic strategy |
Primary outcome
Duration of hospital stay
Time frame: Up to three months from randomization
Time (hours and minutes) from admission to discharge from cardiac department. Reported by clinical personnel in registration form and supplemented by data from the national health registry. Will be evaluated in interim analysis after inclusion of 300 patients in each site.
Combined MACE
Time frame: Within time from randomization to 30 days after randomization
Combined endpoint of major adverse cardiac events, consisting of: "All-cause mortality", "survived cardiac arrest", "Confirmed or Readmission with Acute Coronary Syndrome(ACS)", "Non-scheduled coronary intervention", and "Life-threatening arrhythmias" (see below for description) occuring within time from randomization to 30 days after randomization
7 secondary outcomes
Time to disposition
Time frame: Within 24 h of randomization
Combined MACE
Time frame: Within index admission, within time from discharge to 30, 90, and 365 days after randomization, and within time from randomization to 90 and 365 days after randomization
All-cause mortality
Time frame: Within index admission and within 30, 90 and 365 days of randomization
Survived, cardiac arrest
Time frame: Within index admission and within 30, 90 and 365 days of randomization
Confirmed diagnosis of ACS or readmission with ACS
Time frame: Within index admission and within 30, 90 and 365 days of randomization
Non-scheduled coronary intervention
Time frame: Within index admission and within 30, 90 and 365 days of randomization
Life-threatening arrhythmias
Time frame: Within index admission and within 30, 90 and 365 days of randomization
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 14 Apr 2022.
- BackgroundGrande P, H. L. Akut koronar syndrom, retningslinier for diagnostik og behandling. Dansk Cardiologisk Selskab. 2004 Download from http://www.cardio.dk/docman/doc_download/149-akut-koronart-syndrom. (danish)
- Background: PubMed 23643595Maisel A, Mueller C, Neath SX, Christenson RH, Morgenthaler NG, McCord J, Nowak RM, Vilke G, Daniels LB, Hollander JE, Apple FS, Cannon C, Nagurney JT, Schreiber D, deFilippi C, Hogan C, Diercks DB, Stein JC, Headden G, Limkakeng AT Jr, Anand I, Wu AHB, Papassotiriou J, Hartmann O, Ebmeyer S, Clopton P, Jaffe AS, Peacock WF. Copeptin helps in the early detection of patients with acute myocardial infarction: primary results of the CHOPIN trial (Copeptin Helps in the early detection Of Patients with acute myocardial INfarction). J Am Coll Cardiol. 2013 Jul 9;62(2):150-160. doi: 10.1016/j.jacc.2013.04.011. Epub 2013 Apr 30.
- Background: PubMed 20653710Morgenthaler NG. Copeptin: a biomarker of cardiovascular and renal function. Congest Heart Fail. 2010 Jul;16 Suppl 1:S37-44. doi: 10.1111/j.1751-7133.2010.00177.x.
- Background: PubMed 25960596Reinstadler SJ, Klug G, Feistritzer HJ, Metzler B, Mair J. Copeptin testing in acute myocardial infarction: ready for routine use? Dis Markers. 2015;2015:614145. doi: 10.1155/2015/614145. Epub 2015 Apr 16.
- Background: PubMed 23953697Stengaard C, Sorensen JT, Ladefoged SA, Christensen EF, Lassen JF, Botker HE, Terkelsen CJ, Thygesen K. Quantitative point-of-care troponin T measurement for diagnosis and prognosis in patients with a suspected acute myocardial infarction. Am J Cardiol. 2013 Nov 1;112(9):1361-6. doi: 10.1016/j.amjcard.2013.06.026. Epub 2013 Aug 14.
- Background: PubMed 24786301Mockel M, Searle J, Hamm C, Slagman A, Blankenberg S, Huber K, Katus H, Liebetrau C, Muller C, Muller R, Peitsmeyer P, von Recum J, Tajsic M, Vollert JO, Giannitsis E. Early discharge using single cardiac troponin and copeptin testing in patients with suspected acute coronary syndrome (ACS): a randomized, controlled clinical process study. Eur Heart J. 2015 Feb 7;36(6):369-76. doi: 10.1093/eurheartj/ehu178. Epub 2014 Apr 30.
- Derived from this study: PubMed 37477353Pedersen CK, Stengaard C, Botker MT, Sondergaard HM, Dodt KK, Terkelsen CJ. Accelerated -Rule-Out of acute Myocardial Infarction using prehospital copeptin and in-hospital troponin: The AROMI study. Eur Heart J. 2023 Oct 12;44(38):3875-3888. doi: 10.1093/eurheartj/ehad447.
- Derived from this study: PubMed 30541594Pedersen CK, Stengaard C, Sondergaard H, Dodt KK, Hjort J, Botker MT, Terkelsen CJ. A multicentre, randomized, controlled open-label trial to compare an Accelerated Rule-Out protocol using combined prehospital copeptin and in-hospital high sensitive troponin with standard rule-out in patients suspected of acute Myocardial Infarction - the AROMI trial. Trials. 2018 Dec 12;19(1):683. doi: 10.1186/s13063-018-2990-z.
- Individual participant dataSharing planned: Undecided
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.
Carsten Stengaard, MD, PhD study chair
Aarhus University Hospital Skejby
Hanne M Soendergaard, MD, PhD study chair
Viborg Regional Hospital
Christian J Terkelsen, MD, DmSc, Associate prof. study chair
Aarhus University Hospital Skejby
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated, combined biomarker rule-out strategy for MI in people with Myocardial Infarction, run by Aarhus University Hospital Skejby at 3 sites 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 2 inclusion and 5 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Duration of hospital stay (time frame: Up to three months from randomization). 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 NCT02666326, which also lists 8 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 14 Apr 2022.