Myocardial Infarction Size Reduction With Atorvastatin
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ClinicalTrials.gov Identifier: NCT00286312 |
Recruitment Status :
Completed
First Posted : February 3, 2006
Last Update Posted : May 21, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myocardial Infarction Reperfusion Injury | Drug: Atorvastatin | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | February 2008 |
Actual Study Completion Date : | February 2008 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286312
Netherlands | |
St. Antonius Hospital | |
Nieuwegein, Netherlands, 3435CM | |
University Medical Centre Utrecht | |
Utrecht, Netherlands |
Principal Investigator: | Benno Rensing, MD, PhD | St. Antonius Ziekenhuis Nieuwegein |
ClinicalTrials.gov Identifier: | NCT00286312 |
Other Study ID Numbers: |
RDC-2005-02 |
First Posted: | February 3, 2006 Key Record Dates |
Last Update Posted: | May 21, 2008 |
Last Verified: | May 2008 |
Acute myocardial infarction Primary angioplasty Reperfusion damage Atorvastatin Placebo Early left ventricular remodelling |
Late left ventricular remodelling Cardiac MRI Statin Transluminal, Percutaneous Coronary Angioplasty |
Myocardial Infarction Reperfusion Injury Infarction Ventricular Remodeling Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Postoperative Complications Pathological Conditions, Anatomical Atorvastatin Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |