Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Ratio of myocardial infarct size to area at risk assessed by MRI
Study Overview
Brief Summary
In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) >30.
Detailed Description
After coronary stenting, index of microvascular resistance (IMR) will be measured invasively. Patients with IMR >30 will be randomised to 20 mg alteplase or placebo (NaCl) administered in the culprit vessel through a microcatheter. Magnet resonance imaging (MRI) of the myocardium will be performed early (2-6 days) and late (3 months) to estimate the primary endpoint (infarct size).
10 non-randomised patients, with IMR <30, will undergo the same follow-up as the randomised patients.
Clinical events for all randomised and non-randomised patients will be collected from Swedish national registries and by telephone at 3 and 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Oral and signed informed consent
- •Males and females 18 - 85 years of age
- •Diagnosis of ST-elevation myocardial infarction (STEMI) including occlusion of culprit vessel on angiography
- •Onset of continuous symptoms within 12 hours
- •Have undergone PCI of culprit vessel
- •Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent
Exclusion Criteria
- •Previously known ejection fraction <30%
- •Previous PCI in the culprit vessel
- •Chronic total occlusion in major vessel
- •Any history of bleeding diathesis, known coagulopathy, or will refuse blood transfusions
- •Recent history or known platelet count <100.000 cells/mm3 or Hbg < 10 g/dL
- •Known reduced kidney function with estimated glomerular filtration rate (GFR) <30 ml/min/1.73m
- •Previous hemorrhagic stroke
- •Ongoing oral anticoagulation treatment
- •Severe asthma requiring daily treatment
- •Any mechanical complication (e.g. ventricular septal defect, papillary muscle rupture, cardiac tamponade)
- •Atrioventricular block grade III
- •Known inability to undergo MRI investigation
- •Permanent pacemaker
- •Pronounced claustrophobia
- •Known intolerance to study drug
- •Known intolerance to adenosine
- •Participation in another investigational drug study
- •Previous randomization in the OPTIMAL-PCI trial
Arms & Interventions
Alteplase
40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel
Intervention: alteplase (Drug)
Placebo
40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Ratio of myocardial infarct size to area at risk assessed by MRI
Time Frame: 3 months
MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size
Secondary Outcomes
- Change in hemoglobin(12 hours)
- Level of NtProBNP(12 hours)
- Non invasive CFR(3 months)
- Peak level of Troponin T(12 hours)
- Change of index of microvascular resistance and coronary flow reserve(Immediately after drug administration during invasive index procedure)
- Degree of microvascular obstruction assessed by MRI(2-6 days)
- Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)(12 months)
- Re-hospitalisation for heart failure(12 months)
- Re-hospitalisation for myocardial infarction(12 months)
- Cardiovascular death(12 months)
- Bleeding according to BARC-criteria(7 days)
- Myocardial hemorrhage at MRI(2-6 days)