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Status:

COMPLETED

Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury

Lead Sponsor:

Fibrex Medical Research & Development GmbH

Conditions:

Myocardial Ischemia

Coronary Disease

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.

Eligibility Criteria

Inclusion

  • Patients who have given informed consent
  • Patients after primary percutaneous coronary intervention (PCI) for acute ST-elevation myocardial infarction (STEMI)
  • Men or women with no child bearing potential
  • Onset of symptoms to balloon time \< 6 hours
  • ST-elevation of at least 2 mm in at least 3 leads on 12-lead electrocardiogram (ECG)
  • Primary PCI indicated per standard of care
  • First myocardial infarction (MI)
  • Single index lesion with complete occlusion \[thrombolysis in myocardial infarction (TIMI) flow 0/I\] of one target vessel.

Exclusion

  • History of MI (from patient history, or from ECG)
  • Chest pain or other angina symptoms in the 24 hours before the first recognized symptoms of the acute myocardial infarction (AMI)
  • Need for coronary artery bypass graft (CABG)
  • Administration of any thrombolytic agent since onset of AMI symptoms
  • Serious procedural complications (e.g., procedural unintended occlusion of coronary artery branch, cardiac tamponade, emergency bypass operation, LM dissection, etc.)
  • Presence of cardiogenic shock: hemodynamically unstable and/or need for positive inotropic agents
  • Contraindication to cardiovascular magnetic resonance (CMR): claustrophobia, pacemakers, defibrillators and other electronic devices, and metallic cerebral clips; frequent extrasystoles (\> 12/Min) or atrial fibrillation (AF).
  • Known renal dysfunction defined as serum creatinine \> 250 µmol/l
  • Previous CABG
  • History of congestive heart failure (CHF)
  • Body mass index (BMI) \> 35
  • Patients who cannot communicate reliably with the investigator
  • Patients who are unlikely to cooperate with the requirements of the study
  • Patients who are unwilling and/or unable to give informed consent
  • Patients at increased risk of death from a pre-existing concurrent illness
  • Patients participating in another clinical study
  • Patients who have used any other investigational drugs within 1 month of first dosing
  • Patients who have participated already in this study
  • Patients who are employees at the investigational site; relatives or spouse of the investigator.

Key Trial Info

Start Date :

August 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2007

Estimated Enrollment :

234 Patients enrolled

Trial Details

Trial ID

NCT00326976

Start Date

August 1 2006

End Date

November 1 2007

Last Update

December 4 2007

Active Locations (32)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 8 (32 locations)

1

Allgemeines Krankenhaus Wien

Vienna, Austria, A-1090

2

Wilhelminen-Spital

Vienna, Austria, A-1171

3

Academisch Ziekenhuis van de vrije Universiteit

Brussels, Belgium, B-1090

4

Cliniques Universitaires St-Luc

Brussels, Belgium, B-1200