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Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction

NCT01638806 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2019-04-04

No results posted yet for this study

Summary

Patients with acute myocardial infarction (AMI) are categorized according to the electrocardiogram (ECG) findings into: 1) patients with ST-Elevation Myocardial Infarction (STEMI), 2) patients with Bundle Branch Block Myocardial Infarction (BBBMI), and 3) remaining patients with so-called NON-ST-Elevation Myocardial Infarction (NONSTEMI).

Patients with STEMI or BBBMI are treated with acute angioplasty (PPCI=primary percutaneous coronary intervention), and the sooner PPCI is performed the lower is the mortality. This is why prehospital diagnosis and field-triage of patients with STEMI directly to heart centers with PPCI facilities is recommended.

In patients with NONSTEMI previous trials have indicated that early angioplasty, within 72 hours of symptom onset, is associated with improved outcome when compared to late angioplasty or conservative therapy. No trials have so far been able to diagnose patients with NONSTEMI in the prehospital phase or immediately on arrival at a hospital, and triage them directly to PPCI. Implementation of point-of-care (POC) testing of biomarkers may enable prehospital or early inhospital establishment of the diagnosis NONSTEMI.

The aim of the present trial is to identify patients with NONSTEMI in the prehospital phase or immediately on arrival at the local hospital based on a) symptoms, b) POC testing and c) ECG findings and then randomize patients to I) PPCI, or II) medical therapy and angiography/angioplasty within 72 hours (todays routine).

Se below for detailed description

Conditions

Interventions

PROCEDURE

Group I: Primary PCI

Patients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Christian J Terkelsen, MD,PhD · Department of cardiology B, Aarhus University Hospital in Skejby, Denmark

  • Hans E Bøtker, MD,DmSc,Prof · Department of cardiology B, Aarhus University Hospital in Skejby, Denmark

  • Carsten Stengaard, MD · Department of cardiology B, Aarhus University Hospital in Skejby, Denmark

  • Jacob T Sørensen, MD, PhD · Department of cardiology B, Aarhus Unversity Hospital in Skejby, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Denmark

Study Locations

More Related Trials

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 NCT01638806 on ClinicalTrials.gov