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Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients (HEALTH-DB ACS)

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. Identifier: NCT01678339
Recruitment Status : Withdrawn
First Posted : September 5, 2012
Last Update Posted : October 3, 2012
Information provided by (Responsible Party):

Brief Summary:
Thi is an observational, non interventional, cohort analysis by using administrative databases (drugs treatment, laboratory and diagnostic tests, specialist visits and hospitalizations) of Sicilia region to evaluate treatment patterns of patients after Acute Coronary Syndrome (ACS) event.

Condition or disease
Acute Coronary Syndrome Acute Myocardial Infarction

Detailed Description:

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sicilian Administrative Data Base Study in Acute Coronary Syndrome Patients
Study Start Date : September 2012
Estimated Study Completion Date : December 2012


Primary Outcome Measures :
  1. The diagnostic path for each patient included in the analysis will be described by using all prescription for laboratory test (eg. total cholesterol, LDL cholesterol) and/or diagnostics tests (eg. electrocardiogram) during the observation period. [ Time Frame: up to 2 years ]
  2. The drugs treatment path will be described by using all prescriptions of antihypertensive drugs, lipid-lowering drugs and antiplatelet drugs during the observation period. [ Time Frame: up to 2 years ]
  3. Adherence to treatment will be calculated in the manner suggested by the literature and used in previous publications. Different methods of assessment will, however, used in order to study the variability of results. The analysis will be conducted over [ Time Frame: up to 2 years ]
  4. The chronological analysis of the requirements will allow the identification of potential therapeutic combinations or substitutions. [ Time Frame: up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients discharged alive from an hospitalization for Acute Myocardial Infarction (AMI) between January, 1st 2008 and December, 31st 2010 (inclusion period) will be included into analysis. The discharge date will be defined as "inclusion date".

Inclusion Criteria:

  • Subjects discharged alive from hospitalization for ACS

Exclusion Criteria:

  • All patients that don't have a continuative presence as beneficiaries of the region between January 1st, 2007 and December 31st 2011 will be excluded from analysis.

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 identifier (NCT number): NCT01678339

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Research Site
Palermo, Italy
Sponsors and Collaborators
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Study Chair: Flore La Tour AstraZeneca CLINICAL RESEARCH DIRECTOR
Study Director: Raffaele Sabia AstraZeneca Italy - VP MEDICAL
Principal Investigator: Rosalia Traiana, Doctor of Pharmacology Department of Pharmaceutical Health - SICILIAN REGION
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Responsible Party: AstraZeneca Identifier: NCT01678339    
Other Study ID Numbers: NIS-CIT-XXX-2012/1
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: October 3, 2012
Last Verified: October 2012
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases