Trial | NCT00286312  Report issue

Title

Myocardial Infarction Size Reduction With Atorvastatin
Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
Study Started
Feb 28
2006
Primary Completion
Feb 29
2008
Study Completion
Feb 29
2008
Last Update
May 21
2008
Estimate

Drug Atorvastatin

Criteria 

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
No Results Posted