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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion

Intervention / Treatment
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* Device: Percutaneous Coronary Revascularization for STEMI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI Patients undergoing mechanical reperfusion -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STEMI patients treated in March April 2019<br>Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2019 | Device: Percutaneous Coronary Revascularization for STEMI<br>* Percutaneous Mechanical Reperfusion for STEMI<br>* Other names: Primary angioplasty;|
| STEMI patients treated in March April 2020<br>Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2020 | Device: Percutaneous Coronary Revascularization for STEMI<br>* Percutaneous Mechanical Reperfusion for STEMI<br>* Other names: Primary angioplasty;|

What is the study measuring?
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Primary Outcome Measures

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