Myocardial InfarctionPhase 4NCT00286312
Myocardial Infarction Size Reduction With Atorvastatin
A Phase 4 study testing Atorvastatin in people with Myocardial Infarction and Reperfusion Injury, run by R&D Cardiologie at 2 sites in Netherlands.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Reperfusion Injury
- What is being tested?
- Atorvastatin
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- Feb 2006to Feb 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
St. Antonius Hospital
Nieuwegein, 3435CM
University Medical Centre Utrecht
Utrecht
About this study
Official title: Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study
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.
- Conditions
- Myocardial Infarction, Reperfusion Injury
- Being tested
- Atorvastatin
- 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
- Medical subject headings
- Myocardial Infarction, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Investigators
- Benno Rensing, MD, PhD, Principal investigator, St. Antonius Ziekenhuis Nieuwegein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286312
- Sponsor's protocol ID
- RDC-2005-02
- Status last verified
- May 2008
- First submitted
- 2 Feb 2006
- Last updated
- 21 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Reperfusion Damage and Late Left Ventricular Remodelling With Atorvastatin Administered Before Reperfusion Therapy. The REPERATOR Study
- ClinicalTrials.gov ID
- NCT00286312
- Acronym / sponsor ID
- RDC-2005-02
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- Feb 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin | Drug | – |
Primary outcome
Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benno Rensing, MD, PhD principal investigator
St. Antonius Ziekenhuis Nieuwegein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Myocardial Infarction and Reperfusion Injury, run by R&D Cardiologie at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular end systolic volume index as measured by cine magnetic resonance imaging (MRI) at 3 month follow-up. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2008.