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Myocardial Infarction Size Reduction With Atorvastatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286312
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : May 21, 2008
Sponsor:
Collaborator:
UMC Utrecht
Information provided by:
R&D Cardiologie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Reperfusion Injury Drug: Atorvastatin Phase 4

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up

Secondary Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands, 3435CM
University Medical Centre Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
R&D Cardiologie
UMC Utrecht
Investigators
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Principal Investigator: Benno Rensing, MD, PhD St. Antonius Ziekenhuis Nieuwegein
More Information
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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
Keywords provided by R&D Cardiologie:
Acute myocardial infarction
Primary angioplasty
Reperfusion damage
Atorvastatin
Placebo
Early left ventricular remodelling
 Late left ventricular remodelling
Cardiac MRI
Statin
Transluminal, Percutaneous Coronary
Angioplasty
Additional relevant MeSH terms:
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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