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Myocardial Infarction Size Reduction With Atorvastatin

This study has been completed.
Sponsor:
Collaborator:
UMC Utrecht
Information provided by:
R&D Cardiologie
ClinicalTrials.gov Identifier:
NCT00286312
First received: February 2, 2006
Last updated: May 20, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Myocardial Infarction
Reperfusion Injury
 Drug: Atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by R&D Cardiologie:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: February 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286312

Locations
Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands, 3435CM
University Medical Centre Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
R&D Cardiologie
UMC Utrecht
Investigators
Principal Investigator: Benno Rensing, MD, PhD St. Antonius Ziekenhuis Nieuwegein
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00286312     History of Changes
Other Study ID Numbers: RDC-2005-02
Study First Received: February 2, 2006
Last Updated: May 20, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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:
Infarction
Myocardial Infarction
Reperfusion Injury
Ventricular Remodeling
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Postoperative Complications
 Pathological Conditions, Anatomical
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013