Acute Balloon Angioplasty vs. Traditional Early Invasive Treatment of Non-ST-Elevation Myocardial Infarction

Summary

The purpose of this study is:

A) To determine whether patients with a certain type of heart attack (NSTEMI) can be reliably diagnosed in an ambulance using telemedicine. This is mandatory if NSTEMI patients in the future are to be treated with acute balloon angioplasty (primary PCI).

B) To evaluate whether primary PCI compared with the current regimen of initial medical stabilization and sub-acute PCI results in reduction of infarct-size in NSTEMI-patients.

Conditions

• Myocardial Infarction

Interventions

PROCEDURE

Primary Percutaneous Coronary Intervention

Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.

PROCEDURE

Coronary angiography / Percutaneous coronary intervention

Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.

Sponsors & Collaborators

• Falck Danmark

  collaborator UNKNOWN

• University of Aarhus

  lead OTHER

Principal Investigators

• Jacob T Sorensen, MD · Department of Cardiovascular research, Aarhus University Hospital, Skejby

• Hans E Bøtker, MD, DMSc · Department of Cardiovascular research, Aarhus University Hospital, Skejby

• Kristian A Thygesen, MD, DMSc · Department of Cardiovascular research, Aarhus University Hospital, Aarhus Hospital

• Christian J Terkelsen, MD, PhD · Department of Cardiovascular research, Aarhus University Hospital, Skejby

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2011-03-31

Completion

2011-03-31

Countries

• Denmark