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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

Tracking Information
First Submitted Date  ICMJE February 2, 2006
First Posted Date  ICMJE February 3, 2006
Last Update Posted Date May 21, 2008
Study Start Date  ICMJE February 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2007)
Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
Left ventricular end systolic volume index as measured by cine MRI at 3 months follow-up
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2006)
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,
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myocardial Infarction Size Reduction With Atorvastatin
Official Title  ICMJE Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Myocardial Infarction
  • Reperfusion Injury
Intervention  ICMJE Drug: Atorvastatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 2, 2006)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00286312
Other Study ID Numbers  ICMJE RDC-2005-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE R&D Cardiologie
Collaborators  ICMJE UMC Utrecht
Investigators  ICMJE
Principal Investigator: Benno Rensing, MD, PhD St. Antonius Ziekenhuis Nieuwegein
PRS Account R&D Cardiologie
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP