NCT02894138

Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST-segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	alteplase
DRUG	Placebo

Timeline

• Start date: 2016-09-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2016-09-09
• Last updated: 2021-09-05

Locations

1 site across 1 country: Sweden