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Accelerated Rule Out of Myocardial Infarction (AROMI)

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ClinicalTrials.gov Identifier: NCT02666326
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Christian Juhl Terkelsen, Aarhus University Hospital Skejby

Brief 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. 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:

  1. Reduces admission time by 1.5 hours in patients where AMI is ruled out
  2. Reduces the time to disposition
  3. Is non-inferior compared to the standard rule-out procedure in relation to major adverse cardiovascular events.
  4. Is more cost efficient compared to standard diagnostic strategy

Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Accelerated, combined biomarker rule-out strategy for MI Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4772 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Accelerated Rule-Out of Acute Myocardial Infarction, Using Copeptin and High Sensitive Troponin T - the AROMI Trial
Study Start Date : January 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Conventional diagnostic strategy

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.

Experimental: Accelerated diagnostic strategy
'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.
Procedure: Accelerated, combined biomarker rule-out strategy for MI
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Time to disposition [ Time Frame: Within 24 h of randomization ]
    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.

  2. 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 ]
    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)

  3. All-cause mortality [ Time Frame: Within index admission and within 30, 90 and 365 days of randomization ]
    All-cause mortality registered in the national health registry, occurring from time of admission to discharge, within 30, 90 or 365 days after randomization.

  4. Survived, cardiac arrest [ Time Frame: Within index admission and within 30, 90 and 365 days of randomization ]
    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.

  5. Confirmed diagnosis of ACS or readmission with ACS [ Time Frame: Within index admission and within 30, 90 and 365 days of randomization ]
    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)

  6. Non-scheduled coronary intervention [ Time Frame: Within index admission and within 30, 90 and 365 days of randomization ]
    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

  7. Life-threatening arrhythmias [ Time Frame: Within index admission and within 30, 90 and 365 days of randomization ]
    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.


Other Outcome Measures:
  1. Cost efficiency [ Time Frame: Within index admission, and 1 year after randomization ]
    Costs and cost effectiveness will be evaluated and compared between the two diagnostic strategies.

  2. Risk factors and patient experiences [ Time Frame: Within index admission, and 1 year after randomization ]
    The patients experience of being discharged earlier and risk factors for early readmission.

  3. Myocardial injury [ Time Frame: Within index admission ]
    The laboratory registries is used to determine whether the patient has troponin elevation, from time of admission to discharge. The endpoint committee adjudicate myocardial injury, blinded to the initial randomization. "Universal definition of Myocardial infarction" will be used to evaluate the event.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666326


Contacts
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Contact: Claus K Pedersen, MD 004529635657 claupede@rm.dk

Locations
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Denmark
Department of Cardiology, Viborg Regional Hospital Recruiting
Viborg, Central Denmark Region, Denmark, 8800
Department of Cardiology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Department of Internal Medicine, Horsens Regional Hospital Recruiting
Horsens, Denmark, 8700
Sponsors and Collaborators
Aarhus University Hospital Skejby
Investigators
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Study Chair: Carsten Stengaard, MD, PhD Aarhus University Hospital Skejby
Study Chair: Hanne M Soendergaard, MD, PhD Viborg Regional Hospital
Study Chair: Christian J Terkelsen, MD, DmSc, Associate prof. Aarhus University Hospital Skejby
Study Chair: Karen K Dodt, MD, PhD Horsens Regional Hospital

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)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christian Juhl Terkelsen, Associate professor, MD, DmSc, PhD, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT02666326     History of Changes
Other Study ID Numbers: AROMI-1
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Christian Juhl Terkelsen, Aarhus University Hospital Skejby:
Copeptin
copeptins
Acute Coronary Syndrome
Prehospital emergency care
Biological markers
Troponin
Rule-out
Point-of-Care systems
Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Troponin T
Diagnostic Techniques (Cardiovascular)
High sensitivity troponin

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs