Myocardial Infarction Size Reduction With Atorvastatin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-02-29

Brief Summary

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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

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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.

Conditions

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Myocardial Infarction Reperfusion Injury

Keywords

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Acute myocardial infarction Primary angioplasty Reperfusion damage Atorvastatin Placebo Early left ventricular remodelling Late left ventricular remodelling Cardiac MRI Statin Transluminal, Percutaneous Coronary Angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Benno Rensing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Ziekenhuis Nieuwegein

Locations

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St. Antonius Hospital

Nieuwegein, , Netherlands

Site Status

University Medical Centre Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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RDC-2005-02

Identifier Type: -

Identifier Source: org_study_id