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CompletedNCT00286312Updated May 21, 2008

Myocardial Infarction Size Reduction With Atorvastatin

A Phase 4 interventional study of Atorvastatin in Myocardial Infarction and Reperfusion Injury, sponsored by R&D Cardiologie. Completed at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-05-21.

Sponsored by R&D Cardiologie · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 50 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

R&D Cardiologie is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
50 participants (estimated)

Interventions

  • DrugAtorvastatin
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Other MRI measurements of global and regional left ventricular function

  2. MRI measurements of infarct size at admission, 1 week, and 3 months, as well as changes in these measures between MRI investigations

  3. Biochemical markers of infarct size

  4. Blush grade

07

Study locations

2 sites
  • St. Antonius Hospital
    Nieuwegein, 3435CM, Netherlands
  • University Medical Centre Utrecht
    Utrecht, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00286312
Lead sponsor
R&D Cardiologie
Collaborators
UMC Utrecht
First posted
Feb 3, 2006
Start date
Feb 2006
Primary completion
Feb 2008
Completion
Feb 2008
Last update
May 21, 2008

Study contacts

Benno Rensing, MD, PhD
principal investigator · St. Antonius Ziekenhuis Nieuwegein

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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