NCT04412655

Primary Angioplasty for STEMI During COVID-19 Pandemic (ISACS-STEMI COVID-19) Registry

International Study on Acute Coronary Syndromes - ST-segment Elevation Myocardial Infarction COVID 19

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 6,609 (actual)
• Sponsor: Università degli Studi del Piemonte Orientale Amedeo Avogadro · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The ISACS STEMI COVID-19 has been established in response to the emerging outbreak of COVID-19 to provide a European overview to estimate the real impact of COVID-19 pandemic on treatment and outcome of STEMI by primary angioplasty, and to identify any potential category of patients at risk for delay to treatment or no presentation.

Detailed description

This is a retrospective multicenter registry including at least 40 European primary PCI centers with \> 120 primary PCI/year (with expected average \> 10/month), with the case load of STEMI not expected to be affected by a potential planned reorganization of the STEMI network. The inclusion period will be of 2 months (from March 1st until April 30th). The data will be compared with those retrospectively collected in the same time window of 2019. Inclusion criteria: STEMI treated by primary angioplasty. Primary study outcome: Number of STEMI patients undergoing primary angioplasty. Secondary study outcomes: Ischemia time and the number of late presenters (\> 12 hours from symptoms onset); 3) Door-to-balloon time and the number of patients with a DTB \> 30 minutes); 4) In-Hospital mortality. Data Collection: Data will be collected anonymized through a dedicated CRF. Each center will identify a local Principal Investigator. We will collect information on the study center, demographic, clinical, procedural data. Furthermore, we will collect data on total ischemia time, door-to-balloon time, type of access to the emergency system, COVID positivity, PCI procedure, data on in-hospital mortality.

Conditions

• ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion

Interventions

Type	Name	Description
DEVICE	Percutaneous Coronary Revascularization for STEMI	Percutaneous Mechanical Reperfusion for STEMI

Timeline

• Start date: 2020-05-05
• Primary completion: 2020-05-30
• Completion: 2020-06-02
• First posted: 2020-06-02
• Last updated: 2020-06-11

Locations

1 site across 1 country: Italy