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

NCT ID: NCT04412655

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 6609 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-05
• Study Completion Date: 2020-06-02

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.

Conditions

ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

STEMI patients treated in March April 2019

Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2019

Percutaneous Coronary Revascularization for STEMI

Intervention Type: DEVICE

Percutaneous Mechanical Reperfusion for STEMI

STEMI patients treated in March April 2020

Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2020

Percutaneous Coronary Revascularization for STEMI

Intervention Type: DEVICE

Percutaneous Mechanical Reperfusion for STEMI

Interventions

Percutaneous Coronary Revascularization for STEMI

Percutaneous Mechanical Reperfusion for STEMI

Intervention Type: DEVICE

Other Intervention Names

Primary angioplasty

Eligibility Criteria

Inclusion Criteria

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi del Piemonte Orientale Amedeo Avogadro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Giuseppe De Luca

Novara, , Italy

Countries

Italy

References

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Other Identifiers

115/20

Identifier Type: -

Identifier Source: org_study_id