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Microcirculation In Acute Coronary Syndromes

NCT01382472 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-10-22

No results posted yet for this study

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

Conditions

  • ST Elevation (STEMI) Myocardial Infarction

Interventions

DRUG

Rosuvastatin

40 mg per operative in PPCI, the 40 daily during hospital stay

DRUG

Simvastatin

No statin acutely. Simvastatin 20 mg from day 2.

Sponsors & Collaborators

  • Helse Vest

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Alf Inge Larsen, MD, PhD · Helse Stavanger HF

  • Noreen Butt, MD · Helse Stavanger HF

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382472 on ClinicalTrials.gov