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Microcirculation In Acute Coronary Syndromes (MICROS)

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ClinicalTrials.gov Identifier: NCT01382472
Recruitment Status : Unknown
Verified August 2016 by Helse Stavanger HF.
Recruitment status was:  Recruiting
First Posted : June 27, 2011
Last Update Posted : August 25, 2016
Sponsor:
Collaborators:
Helse Vest
University Hospital of North Norway
St. Olavs Hospital
Information provided by (Responsible Party):
Helse Stavanger HF

Brief 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. The investigators want to assess if early high dose statin therapy in patients treated with primary PCI:

  1. reduces area of myocardial infarction, reduces volumes and improves remodelling as assessed by MRI at 2 days and at 2 months
  2. improves microcirculation (Decreased number of patients with MO) as assessed by first pass time estimated with MRI 2 days
  3. have impact on coronary blood flow as assessed by intravascular registrations and TIMI frame count immediately after PCI
  4. 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
  5. improves endothelial function assessed by flow mediated vasodilatation at discharge
  6. alters Peak VO2 at 1 and 6 month
  7. reduce levels of CRP and pro-inflammatory cytokines during index hospitalization and at follow-up alters collagen turnover

Condition or disease Intervention/treatment Phase
ST Elevation (STEMI) Myocardial Infarction Drug: Rosuvastatin Drug: Simvastatin Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MICROS-Pilot Study Microcirculation In Acute Coronary Syndromes; Effect of Pre-treatment of High Dose Rosuvastatin on Coronary Microcirculation in Primary PCI
Study Start Date : September 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rosuvastatin
40 mg rosuvastatin pre PCI and daily during hospital stay
Drug: Rosuvastatin
40 mg per operative in PPCI, the 40 daily during hospital stay
Other Name: Crestor-AstraZeneca

Historical data (KOMPIS)
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.
Drug: Simvastatin
No statin acutely. Simvastatin 20 mg from day 2.




Primary Outcome Measures :
  1. infarct size [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Evidence of acute ST elevation myocardial infarct.
  • Planned primary PCI procedure.
  • Obtained written informed consent.
  • "One vessel disease"

Exclusion Criteria:

  • 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)
  • Lactating females
  • Asians
  • Previous muscle disease
  • Reduced glomerular filtration
  • Active hepatic disease
  • Ongoing oral anticoagulation therapy
  • Ongoing cyclosporine therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382472


Locations
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Norway
Stavanger University Hospital Recruiting
Stavanger, Norway, 4068
Contact: Alf Inge Larsen, MD, PhD    +4751513201    laai@sus.no   
Principal Investigator: Noreen Butt, MD         
University Hospital of North Norway Recruiting
Tromsø, Norway, NO-9038
Contact: Terje Steigen, MD, PhD    +4791507766    terje.steigen@unn.no   
Principal Investigator: Terje Steigen, MD PhD         
St. Olavs Hospital Not yet recruiting
Trondheim, Norway, NO-7006
Contact: Rune Wiseth, MD, PhD    +4772573000    rune.wiseth@ntnu.no   
Principal Investigator: Rune Wiseth, MD, PhD         
Sponsors and Collaborators
Helse Stavanger HF
Helse Vest
University Hospital of North Norway
St. Olavs Hospital
Investigators
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Study Chair: Alf Inge Larsen, MD, PhD Helse Stavanger HF
Principal Investigator: Noreen Butt, MD Helse Stavanger HF
Principal Investigator: Terje Steigen, MD, PhD University Hospital of North Norway
Principal Investigator: Rune Wiseth, MD, PhD St. Olavs Hospital

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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT01382472     History of Changes
Other Study ID Numbers: MICROS
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Helse Stavanger HF:
STEMI
PPCI
Statins
Infarct size

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin Calcium
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors