NCT Number: NCT00286312
Myocardial Infarction Size Reduction With Atorvastatin
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
St. Antonius Hospital, Nieuwegein, Netherlands
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
R&D Cardiologie
Other
Collaborators
- UMC Utrecht
Registry information
Official study title
Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study
Important dates
- Study start
- 2006
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Feb 3, 2006
- Registry last updated
- May 21, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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