Myocardial Infarction Size Reduction With Atorvastatin

This study has been completed.
Sponsor:
Collaborator:
UMC Utrecht
Information provided by:
R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT00286312
First received: February 2, 2006
Last updated: May 20, 2008
Last verified: May 2008

February 2, 2006
May 20, 2008
February 2006
February 2008   (final data collection date for primary outcome measure)
Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
Left ventricular end systolic volume index as measured by cine MRI at 3 months follow-up
Complete list of historical versions of study NCT00286312 on ClinicalTrials.gov Archive Site
  • Other MRI measurements of global and regional left ventricular function
  • MRI measurements of infarct size at admission, 1 week, and 3 months, as well as changes in these measures between MRI investigations
  • Biochemical markers of infarct size
  • Blush grade
Other MRI measurements of global and regional left ventricular function. MRI measurements of infarct size at admission, 1 week and 3 months as well as changes in these measures between MRI investigations. Biochemical markers of infarct size. Blush grade,
Not Provided
Not Provided
 
Myocardial Infarction Size Reduction With Atorvastatin
Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study

The purpose of this study is to determine if oral atorvastatin administered just before percutaneous coronary angioplasty for acute myocardial infarction improves early and late heart function as compared to placebo.

Left ventricular remodelling after a myocardial infarction refers to changes in shape and function of the infarcted and uninfarcted myocardium. Remodelling begins minutes after acute myocardial infarction and may continue for months or years, leading to dilation of the left ventricle (LV) and an increased LV volume. As studies show, LV volume strongly correlates with long-term mortality. Reperfusion after a period of ischaemia (through medication or PTCA) leads to so-called 'reperfusion injury'. This results in myocardial dysfunction and damage, which can lead to LV remodelling.

In a study where atorvastatin was administered at the onset of reperfusion infarct size was reduced. Atorvastatin led to protection of the reperfused myocardium, independently of its effects on cholesterol.

The objective is to measure the effect of atorvastatin, administered orally before reperfusion therapy by PTCA, on infarct size and microvascular reperfusion.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Myocardial Infarction
  • Reperfusion Injury
Drug: Atorvastatin
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Consecutive patients (aged > 18 years) who are to undergo a primary PCI for a first acute ST elevation myocardial infarction will be asked to participate in this study.

Exclusion Criteria:

  • Previous myocardial infarction
  • Previous coronary artery bypass grafting (CABG)
  • Cardiac rhythm is other than normal sinus rhythm.
  • Electrical instability.
  • The patient is in Killip class 3 or 4 of heart failure.
  • Need for intra aortic balloon counterpulsation therapy
  • The patient is unable to hold his/her breath for up to 20 seconds due to age or concomitant illness.
  • Implanted electronic devices are present: pacemakers, internal defibrillators, ECG-registration devices, neurostimulators, implanted drug infusion devices, cochlear implants etc.
  • Previous vascular surgery: aneurysm clip, carotid artery vascular clamp, aortic clips, or venous umbrella
  • Prosthesis (orbital/penile, etc.)
  • Spinal/intra-ventricular shunts.
  • Swan-Ganz catheter; transdermal delivery systems.
  • Metal fragments: eye, head, ear, skin.
  • Implants held by magnets.
  • Known allergy to MR contrast media
  • Prior use of statins
  • No PCI performed
  • No recanalisation achieved
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00286312
RDC-2005-02
No
Not Provided
R&D Cardiologie
UMC Utrecht
Principal Investigator: Benno Rensing, MD, PhD St. Antonius Ziekenhuis Nieuwegein
R&D Cardiologie
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP