Accelerated Rule Out of Myocardial Infarction

NCT02666326 | Completed DMC

• 1 other identifier: AROMI-1
• Study Type: interventional
• Target: 4,516
• Locations: 1 country
• Sites: 3

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

Conditions

Myocardial Infarction

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Within time from randomization to 30 days after randomization

Secondary Outcomes (7)

• Time to disposition

  Within 24 h of randomization

• Combined MACE

  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

  Within index admission and within 30, 90 and 365 days of randomization

• Survived, cardiac arrest

  Within index admission and within 30, 90 and 365 days of randomization

• Confirmed diagnosis of ACS or readmission with ACS

  Within index admission and within 30, 90 and 365 days of randomization

Other Outcomes (3)

• Cost efficiency

  Within index admission, and 1 year after randomization

• Risk factors and patient experiences

  Within index admission, and 1 year after randomization

• Myocardial injury

  Within index admission

Study Arms (2)

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.

Procedure: Accelerated, combined biomarker rule-out strategy for MI

Interventions

Accelerated, combined biomarker rule-out strategy for MI PROCEDURE

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.

Accelerated diagnostic strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (3)

Department of Cardiology, Viborg Regional Hospital

Viborg, Central Jutland, 8800, Denmark

Location

Department of Cardiology, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Department of Internal Medicine, Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Related Publications (8)

• 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)

  BACKGROUND

• 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.

  PMID: 23643595 BACKGROUND

• Morgenthaler 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.

  PMID: 20653710 BACKGROUND

• Reinstadler 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.

  PMID: 25960596 BACKGROUND

• Stengaard 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.

  PMID: 23953697 BACKGROUND

• Mockel 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.

  PMID: 24786301 BACKGROUND

• Pedersen 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.

  PMID: 37477353 DERIVED

• Pedersen 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.

  PMID: 30541594 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome; Diabetes Insipidus; Infarction; Cardiovascular Diseases; Heart Diseases; Ischemia; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• 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

  Regionshospitalet Horsens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, DmSc, PhD

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: January 28, 2016
• Study Start: January 25, 2016
• Primary Completion: October 3, 2019
• Study Completion: September 3, 2020
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

DK (3)