Myocardial Infarction Size Reduction With Atorvastatin - Full Text View

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction Reperfusion Injury	Drug: Atorvastatin	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Heart Attack

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by R&D Cardiologie:

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


Estimated Enrollment:	50
Study Start Date:	February 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286312

Locations


Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands, 3435CM
University Medical Centre Utrecht
Utrecht, Netherlands

Sponsors and Collaborators

R&D Cardiologie

UMC Utrecht

Investigators


Principal Investigator:	Benno Rensing, MD, PhD	St. Antonius Ziekenhuis Nieuwegein

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00286312 History of Changes
Other Study ID Numbers:	RDC-2005-02
Study First Received:	February 2, 2006
Last Updated:	May 20, 2008
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by R&D Cardiologie:


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

Additional relevant MeSH terms:


Infarction Myocardial Infarction Reperfusion Injury Ventricular Remodeling Cardiovascular Diseases Heart Diseases Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Anatomical Postoperative Complications	Vascular Diseases Atorvastatin Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015