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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412655
Recruitment Status : Active, not recruiting
First Posted : June 2, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
ST Elevated Myocardial Infarction Undergoing Mechanical Reperfusion Device: Percutaneous Coronary Revascularization for STEMI

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.

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Study Type : Observational
Actual Enrollment : 6609 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: International Study on Acute Coronary Syndromes - ST-segment Elevation Myocardial Infarction COVID 19
Actual Study Start Date : May 5, 2020
Actual Primary Completion Date : May 30, 2020
Estimated Study Completion Date : June 2, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
STEMI patients treated in March April 2019
Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2019
Device: Percutaneous Coronary Revascularization for STEMI
Percutaneous Mechanical Reperfusion for STEMI
Other Name: Primary angioplasty

STEMI patients treated in March April 2020
Patients with STEMI undergoing mecahnical revascularization from 1th March to 30th April 2020
Device: Percutaneous Coronary Revascularization for STEMI
Percutaneous Mechanical Reperfusion for STEMI
Other Name: Primary angioplasty




Primary Outcome Measures :
  1. Number of patients undergoing primary angioplasty [ Time Frame: March April 2019 and 2020 ]
    Number of patients undergoing primary angioplasty

  2. Number of patients undergoing primary angioplasty later than 12 hours from symptoms onset; [ Time Frame: March April 2019 and 2020 ]
    Number of patients undergoing primary angioplasty later 12 hours from symptoms onset;

  3. Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission [ Time Frame: March April 2019 and 2020 ]
    Number of patients undergoing primary angioplasty later than 30 minutes from PCI hospital admission

  4. In-hospital mortality [ Time Frame: March April 2019 and 2020 ]
    In-Hospital mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
STEMI Patients undergoing mechanical reperfusion
Criteria

Inclusion Criteria: STEMI Patients undergoing mechanical reperfusion

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412655


Locations
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Italy
Giuseppe De Luca
Novara, Italy, 28100
Sponsors and Collaborators
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
ClinicalTrials.gov Identifier: NCT04412655    
Other Study ID Numbers: 115/20
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases