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Completed

NCT Number: NCT00286312

Myocardial Infarction Size Reduction With Atorvastatin

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Antonius Hospital, Nieuwegein, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Primary outcomes

  1. Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up

Secondary outcomes

  1. Other MRI measurements of global and regional left ventricular function

  2. MRI measurements of infarct size at admission, 1 week, and 3 months, as well as changes in these measures between MRI investigations

  3. Biochemical markers of infarct size

  4. Blush grade

Sponsors and collaborators

Lead sponsor

R&D Cardiologie

Other

Collaborators

  • UMC Utrecht

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 3, 2006
Registry last updated
May 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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