Clinical Governance of Patients With Acute Coronary Syndrome in Italy

  • STATUS
    Recruiting
  • participants needed
    3000
  • sponsor
    Foundation IRCCS San Matteo Hospital
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Updated on 16 February 2024
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depression
ischemia
myocardial infarction
stemi
infarct
acute coronary syndrome
coronary disease
troponin

Summary

This is a prospective, observational, multicenter study that enroll consecutive and all-comers patients hospitalized with a diagnosis of Acute Coronary Syndrome (ACS) at admission.

Description

This is a Quality Improvement Program which enroll all the consecutive patients hospitalized with ACS. The data elements that are central to the study include the primary and secondary quality indicators (QIs) that are used to define the performance and to promote improved quality of care.

At least 3000 patients will be enrolled. The primary endpoint are assessed in-hospital, at admission and discharge. Patients will be followed for 1 year after the ACS.

Details
Condition Acute Coronary Syndrome, Ischemic Heart Disease
Age 18years - 100years
Clinical Study IdentifierNCT04255537
SponsorFoundation IRCCS San Matteo Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

STEACS patients: symptoms of myocardial ischemia and persistent (i.e. > 20 min) ST elevation in at least two contiguous ECG leads. N.B. Positive biomarkers of cardiac necrosis (i.e. troponin) are not required to confirm the diagnosis. New or presumably new left-bundle branch block at presentation occurs infrequently, may interfere with ST-elevation analysis, and should not be considered diagnostic of acute myocardial infarction (MI) in isolation
NSTE-ACS patients: symptoms of myocardial ischemia of at least 10 minutes without persistent ST elevation in at least two contiguous ECG leads. To be included in this category patients should have at least one of the following two conditions: a) ECG evidence of NSTEACS defined as T wave inversion in leads with dominant R waves of at least of at least 1 mm (100 V) or ST segment depression of at least 0.5 mm (50 V) and/or b) Biomarker evidence of NSTEACS defined as at least one positive (i.e. above the 99th percentile upper reference limit) troponin value (i.e. NSTEMI)
A written informed consent (to agree for a contact, usually by telephone) is required only to patients who are discharged alive

Exclusion Criteria

Subjects who, in the opinion of the investigator, are unable to comply with study follow up procedures, including, but not limited to, patients who are in prison, who are expected to move to a remote country, or who refuse to be followed should be excluded
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