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Accelerated Rule Out of Myocardial Infarction

NCT02666326 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4516

Last updated 2022-04-14

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Carsten Stengaard, MD, PhD · Aarhus University Hospital Skejby

  • Hanne M Soendergaard, MD, PhD · Viborg Regional Hospital

  • Christian J Terkelsen, MD, DmSc, Associate prof. · Aarhus University Hospital Skejby

  • Karen K Dodt, MD, PhD · Regionshospitalet Horsens

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-25
Primary Completion
2019-10-03
Completion
2020-09-03

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666326 on ClinicalTrials.gov