Clinical trial NCT00286312: Myocardial Infarction Size Reduction With Atorvastatin
Official title: Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Reperfusion Injury
Keywords: Acute myocardial infarction
Primary angioplasty
Reperfusion damage
Atorvastatin
Placebo
Early left ventricular remodelling
Late left ventricular remodelling
Cardiac MRI
Statin
Transluminal, Percutaneous Coronary
Angioplasty
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
First posted: 2006-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
Secondary outcomes:
measure: Other MRI measurements of global and regional left ventricular function
measure: MRI measurements of infarct size at admission, 1 week, and 3 months, as well as changes in these measures between MRI investigations
measure: Biochemical markers of infarct size
measure: Blush grade
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
Study officials:
affiliation: St. Antonius Ziekenhuis Nieuwegein
name: Benno Rensing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: