Myocardial Infarction Size Reduction With Atorvastatin

NCT00286312 | Completed Phase 4

• 1 other identifier: RDC-2005-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up

Secondary Outcomes (4)

• 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

Interventions

Atorvastatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• R&D Cardiologie: lead
• UMC Utrecht: collaborator

Study Sites (2)

St. Antonius Hospital

Nieuwegein, 3435CM, Netherlands

Location

University Medical Centre Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Myocardial Infarction; Reperfusion Injury

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Postoperative Complications

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Benno Rensing, MD, PhD

  St. Antonius Ziekenhuis Nieuwegein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 3, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 21, 2008

Record last verified: 2008-05

Locations

NL (2)