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Myocardial Infarction Size Reduction With Atorvastatin

Primary Purpose

Myocardial Infarction, Reperfusion Injury

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
R&D Cardiologie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Acute myocardial infarction, Primary angioplasty, Reperfusion damage, Atorvastatin, Placebo, Early left ventricular remodelling, Late left ventricular remodelling, Cardiac MRI, Statin, Transluminal, Percutaneous Coronary, Angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Antonius Hospital
  • University Medical Centre Utrecht

Outcomes

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

Full Information

First Posted
February 2, 2006
Last Updated
May 20, 2008
Sponsor
R&D Cardiologie
Collaborators
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT00286312
Brief Title
Myocardial Infarction Size Reduction With Atorvastatin
Official Title
Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
R&D Cardiologie
Collaborators
UMC Utrecht

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Reperfusion Injury
Keywords
Acute myocardial infarction, Primary angioplasty, Reperfusion damage, Atorvastatin, Placebo, Early left ventricular remodelling, Late left ventricular remodelling, Cardiac MRI, Statin, Transluminal, Percutaneous Coronary, Angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
Secondary Outcome Measure Information:
Title
Other MRI measurements of global and regional left ventricular function
Title
MRI measurements of infarct size at admission, 1 week, and 3 months, as well as changes in these measures between MRI investigations
Title
Biochemical markers of infarct size
Title
Blush grade

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benno Rensing, MD, PhD
Organizational Affiliation
St. Antonius Ziekenhuis Nieuwegein
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
University Medical Centre Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

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Myocardial Infarction Size Reduction With Atorvastatin

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