ST Elevation (STEMI) Myocardial InfarctionPhase 4MICROSNCT01382472
Microcirculation In Acute Coronary Syndromes
A Phase 4 study testing Rosuvastatin and Simvastatin in people with ST Elevation (STEMI) Myocardial Infarction, run by Helse Stavanger HF at 3 sites in Norway.
Trial summary
In this mechanistic pilot study in 40 patients the investigators will compare the findings in patients treated with very early high dose statin therapy with historic controls from the KOMPIS study published in EHJ 200925. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- ST Elevation (STEMI) Myocardial Infarction
- What is being tested?
- Rosuvastatin and Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesNorway
- Study dates
- Sep 2011to Dec 2016
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Evidence of acute ST elevation myocardial infarct.
- Planned primary PCI procedure.
- Obtained written informed consent.
- "One vessel disease"
Who cannot join
- History of previous myocardial infarction
- History of valvular disease
- Ongoing therapy for hyperlipidemia
- History of heart failure
- Any active non-cardiac co-morbidity or condition that is likely to compromise patient cooperation or survival during the follow-up period of the study.
- Pregnancy (In doubt a urine test will be employed before treatment)
Show all 13Show fewer
- Lactating females
- Asians
- Previous muscle disease
- Reduced glomerular filtration
- Active hepatic disease
- Ongoing oral anticoagulation therapy
- Ongoing cyclosporine therapy
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Stavanger University Hospital
Stavanger, 4068
University Hospital of North Norway
Tromsø, NO-9038
St. Olavs Hospital
Trondheim, NO-7006
About this study
Official title: MICROS-Pilot Study Microcirculation In Acute Coronary Syndromes; Effect of Pre-treatment of High Dose Rosuvastatin on Coronary Microcirculation in Primary PCI
In this mechanistic pilot study in 40 patients the investigators will compare the findings in patients treated with very early high dose statin therapy with historic controls from the KOMPIS study published in EHJ 200925. The investigators want to assess if early high dose statin therapy in patients treated with primary PCI:
- reduces area of myocardial infarction, reduces volumes and improves remodelling as assessed by MRI at 2 days and at 2 months
- improves microcirculation (Decreased number of patients with MO) as assessed by first pass time estimated with MRI 2 days
- have impact on coronary blood flow as assessed by intravascular registrations and TIMI frame count immediately after PCI
- reduce levels of CK-MB and TnT measured as area under the curve during the hospital stay at improves neurohumoral profile assessed by Heart Rate Variability (HRV) and neurohormones at discharge and at 2 months follow-up
- improves endothelial function assessed by flow mediated vasodilatation at discharge
- alters Peak VO2 at 1 and 6 month
- reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at follow-up alters collagen turnover
Read the detailed description
Impairment of the myocardial microcirculation in the setting of AMI is multifactorial in etiology. This may be due to vasoactive factors including endothelin-1, which is a potent vasoconstricting peptide and increasingly expressed in the active plaque . Oxidative stress and ischaemia per se may also reduce the bioavailability of nitric oxide, further contributing to the dysfunction of the myocardial microcirculation.
Statins have been shown to benefit ACS patients in that they are believed to decrease reperfusion injury after an ischemic event, promote plaque stabilization, and reduce inflammation in ACS patients. In patients admitted with acute coronary syndrome (ACS), treatment with statins <24 hours of presentation was associated with lower incidences of death, stroke, reinfarction, heart failure, and pulmonary edema compared with delayed administration .
40 statin naive patients admitted with STEMI will receive high dose statin Rosuvastatin 40 mg pre/per primary PCI and continue this treatment during the hospital stay. The high dose of rosuvastatin is chosen to achieve high plasma concentration as early as possible for per conditioning of the myocardium at risk. At discharge they will be switched to standard dose statin.
Myocardial infarction will be assessed with Contrast enhanced cardiac magnetic resonance at 2 days and at 2 months. Microvascular obstruction (MO) may be assessed by first- pass perfusion (FPP) and delayed hyper enhancement (DHE) MO is defined as regional hypoperfusion on first-pass perfusion as previously described . The investigators have recently demonstrated that MO as verified by CMR following MI may allow early identification of patients with a high risk of LV remodeling likely to benefit from pharmacological therapy .
Blood tests for assessment of collagen turnover, neurohumoral activation and inflammation will be drawn daily during hospital stay.
The Results will be compared with the findings of statin naive patients from tha KOMPIS trial who were not treated with high dose pre and per operative statins
- Being tested
- Rosuvastatin, Simvastatin
- Keywords
- STEMI, PPCI, Statins, Infarct size
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor-AstraZeneca
40 mg per operative in PPCI, the 40 daily during hospital stay
SimvastatinDrug
No statin acutely. Simvastatin 20 mg from day 2.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | 40 mg rosuvastatin pre PCI and daily during hospital stay Receives: Drug: Rosuvastatin |
| Historical data (KOMPIS) | Other | Patients from the KOMPIS trial (n=44) will be used as historical controls. They received no statins omn the first day. Low dose simvastatin during hospital stay. Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
infarct size
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation (STEMI) 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- Helse Vest, University Hospital of North Norway, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Alf Inge Larsen, MD, PhD, Study chair, Helse Stavanger HFNoreen Butt, MD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382472
- Sponsor's protocol ID
- MICROS
- Acronym
- MICROS
- Status last verified
- Aug 2016
- First submitted
- 20 Jun 2011
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICROS-Pilot Study Microcirculation In Acute Coronary Syndromes; Effect of Pre-treatment of High Dose Rosuvastatin on Coronary Microcirculation in Primary PCI
- ClinicalTrials.gov ID
- NCT01382472
- Acronym / sponsor ID
- MICROS / MICROS
- Keywords
- STEMI, PPCI, Statins, Infarct size
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Helse Vest, University Hospital of North Norway, St. Olavs Hospital
- Study start
- Sep 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jun 2011 (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.
In this mechanistic pilot study in 40 patients the investigators will compare the findings in patients treated with very early high dose statin therapy with historic controls from the KOMPIS study published in EHJ 200925. The investigators want to assess if early high dose statin therapy in patients treated with primary PCI:
- reduces area of myocardial infarction, reduces volumes and improves remodelling as assessed by MRI at 2 days and at 2 months
- improves microcirculation (Decreased number of patients with MO) as assessed by first pass time estimated with MRI 2 days
- have impact on coronary blood flow as assessed by intravascular registrations and TIMI frame count immediately after PCI
- reduce levels of CK-MB and TnT measured as area under the curve during the hospital stay at improves neurohumoral profile assessed by Heart Rate Variability (HRV) and neurohormones at discharge and at 2 months follow-up
- improves endothelial function assessed by flow mediated vasodilatation at discharge
- alters Peak VO2 at 1 and 6 month
- reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at follow-up alters collagen turnover
Detailed description
Impairment of the myocardial microcirculation in the setting of AMI is multifactorial in etiology. This may be due to vasoactive factors including endothelin-1, which is a potent vasoconstricting peptide and increasingly expressed in the active plaque . Oxidative stress and ischaemia per se may also reduce the bioavailability of nitric oxide, further contributing to the dysfunction of the myocardial microcirculation.
Statins have been shown to benefit ACS patients in that they are believed to decrease reperfusion injury after an ischemic event, promote plaque stabilization, and reduce inflammation in ACS patients. In patients admitted with acute coronary syndrome (ACS), treatment with statins <24 hours of presentation was associated with lower incidences of death, stroke, reinfarction, heart failure, and pulmonary edema compared with delayed administration .
40 statin naive patients admitted with STEMI will receive high dose statin Rosuvastatin 40 mg pre/per primary PCI and continue this treatment during the hospital stay. The high dose of rosuvastatin is chosen to achieve high plasma concentration as early as possible for per conditioning of the myocardium at risk. At discharge they will be switched to standard dose statin.
Myocardial infarction will be assessed with Contrast enhanced cardiac magnetic resonance at 2 days and at 2 months. Microvascular obstruction (MO) may be assessed by first- pass perfusion (FPP) and delayed hyper enhancement (DHE) MO is defined as regional hypoperfusion on first-pass perfusion as previously described . The investigators have recently demonstrated that MO as verified by CMR following MI may allow early identification of patients with a high risk of LV remodeling likely to benefit from pharmacological therapy .
Blood tests for assessment of collagen turnover, neurohumoral activation and inflammation will be drawn daily during hospital stay.
The Results will be compared with the findings of statin naive patients from tha KOMPIS trial who were not treated with high dose pre and per operative statins
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin40 mg rosuvastatin pre PCI and daily during hospital stay |
| Historical data (KOMPIS) | Other | Drug: SimvastatinPatients from the KOMPIS trial (n=44) will be used as historical controls. They received no statins omn the first day. Low dose simvastatin during hospital stay. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Evidence of acute ST elevation myocardial infarct.
- Planned primary PCI procedure.
- Obtained written informed consent.
- "One vessel disease"
Key exclusion criteria (13 listed)
- History of previous myocardial infarction
- History of valvular disease
- Ongoing therapy for hyperlipidemia
- History of heart failure
- Any active non-cardiac co-morbidity or condition that is likely to compromise patient cooperation or survival during the follow-up period of the study.
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 |
|---|---|---|
| RosuvastatinAlso: Crestor-AstraZeneca40 mg per operative in PPCI, the 40 daily during hospital stay | Drug | Rosuvastatin |
| SimvastatinNo statin acutely. Simvastatin 20 mg from day 2. | Drug | Historical data (KOMPIS) |
Primary outcome
infarct size
Time frame: 2 years
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 22 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Alf Inge Larsen, MD, PhD study chair
Helse Stavanger HF
Noreen Butt, MD principal investigator
Helse Stavanger HF
3 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 Rosuvastatin and Simvastatin in people with ST Elevation (STEMI) Myocardial Infarction, run by Helse Stavanger HF at 3 sites in Norway.
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 5 inclusion and 13 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
infarct size (time frame: 2 years). 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 22 Oct 2020.