Myocardial Infarction Size Reduction With Atorvastatin

Myocardial Infarction Clinical Trial

Official title:

Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286312
• Other study ID #: RDC-2005-02
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2006
• Last updated: May 20, 2008
• Start date: February 2006
• Est. completion date: February 2008

Study information

• Verified date: May 2008
• Source: R&D Cardiologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Reperfusion Injury
• Ventricular Remodeling

Intervention

Drug:
• Atorvastatin

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	University Medical Centre Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
R&D Cardiologie	UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
Secondary	Other MRI measurements of global and regional left ventricular function
Secondary	MRI measurements of infarct size at admission, 1 week, and 3 months, as well as changes in these measures between MRI investigations
Secondary	Biochemical markers of infarct size
Secondary	Blush grade