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

• Conditions: ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion
• Interventions: Device: Percutaneous Coronary Revascularization for STEMI

• Registration Number: NCT04412655
• Lead Sponsor: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Brief 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.

Study Timeline

• Study Start: 2020-05-05
• Primary Completion: 2020-05-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study Completion: 2020-06-02
• Study First Posted: 2020-06-02
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6609

Inclusion Criteria

STEMI Patients undergoing mechanical reperfusion

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STEMI patients treated in March April 2020	Percutaneous Coronary Revascularization for STEMI	Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2020
STEMI patients treated in March April 2019	Percutaneous Coronary Revascularization for STEMI	Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2019

Primary Outcome Measures

Name	Time	Method
Number of patients undergoing primary angioplasty	March April 2019 and 2020	Number of patients undergoing primary angioplasty
Number of patients undergoing primary angioplasty later than 12 hours from symptoms onset;	March April 2019 and 2020	Number of patients undergoing primary angioplasty later 12 hours from symptoms onset;
In-hospital mortality	March April 2019 and 2020	In-Hospital mortality
Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission	March April 2019 and 2020	Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission

Trial Locations

Locations (1)

Giuseppe De Luca; 🇮🇹 Novara, Italy