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

ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion Clinical Trial

— ISACS-STEMI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04412655
• Other study ID #: 115/20
• Status: Active, not recruiting
• Start date: May 5, 2020
• Est. completion date: June 2, 2020

Study information

• Verified date: June 2020
• Source: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6609
• Est. completion date: June 2, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: STEMI Patients undergoing mechanical reperfusion

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Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion
• ST Elevation Myocardial Infarction

Intervention

Device:
• Percutaneous Coronary Revascularization for STEMI
Percutaneous Mechanical Reperfusion for STEMI

Locations

Country	Name	City	State
Italy	Giuseppe De Luca	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients undergoing primary angioplasty	Number of patients undergoing primary angioplasty	March April 2019 and 2020
Primary	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
Primary	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
Primary	In-hospital mortality	In-Hospital mortality	March April 2019 and 2020