- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01061086
An Epidemiological Study of Acute Coronary Syndromes in The Greek Population. The TARGET Study (TARGET)
December 20, 2011 updated by: AstraZeneca
An Epidemiological Study of Acute Coronary Syndromes in The Greek Population
This is a multicenter, 2-phase observational study of acute coronary syndromes (ACS) in Greece, designed to provide real world data on the risk factors of patients presenting to a hospital emergency department with an index event, as well as to depict the current management practices and outcomes of these clinical conditions in Greece.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
418
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chalkida, Greece
- Research Site
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Chios, Greece
- Research Site
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Attiki
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Athens, Attiki, Greece
- Research Site
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Chanion
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Chania, Chanion, Greece
- Research Site
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Herakliou
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Heraklion, Herakliou, Greece
- Research Site
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Ioanninon
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Ioannina, Ioanninon, Greece
- Research Site
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Kozani
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Ptolemaida, Kozani, Greece
- Research Site
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Larrisis
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Larissa, Larrisis, Greece
- Research Site
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Magnisias
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Volos, Magnisias, Greece
- Research Site
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Pella
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Eddesa, Pella, Greece
- Research Site
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Rodopi
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Komotini, Rodopi, Greece
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Emergency Room
Description
Inclusion Criteria:
- Diagnosis of an ACS (STEMI, NSTEMI, UA).
- Informed Consent
Exclusion Criteria:
- Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the study sites).
- Participation in other clinical study in period between the index event and 6- month follow-up assessment with the exception of registering in registries or surveys not influencing the management of the ACS.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Patients over 18 years old admitted to the hospital with Acute Coronary Syndrome.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate the proportion of patients who are on target for LDL-C according to the 2004-updated NCEP ATPIII guidelines as calculated within the first 24-hours of hospital admission for an ACS.
Time Frame: first visit - 1st day (cross-sectional part)
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first visit - 1st day (cross-sectional part)
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To estimate the proportion of patients enrolled in the cross-sectional part of the study that experiences a Major Adverse Cardiovascular Event (MACE) within a 6-month follow-up period.
Time Frame: follow up visit - 6th month (prospective part)
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follow up visit - 6th month (prospective part)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To estimate the proportion of patients admitted to the hospital with STEMI, NSTEMI and unstable angina.
Time Frame: first visit - 1st day (cross-sectional part)
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first visit - 1st day (cross-sectional part)
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To estimate the "pain-to-door-time" throughout different regions in Greece.
Time Frame: first visit - 1st day (cross-sectional part)
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first visit - 1st day (cross-sectional part)
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To estimate the time to first MACE and to estimate CV, non-CV and all cause mortality within the 6-month period following the index ACS event.
Time Frame: follow up visit - 6th month (prospective part)
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follow up visit - 6th month (prospective part)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Panagiotis Pontikis, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
February 1, 2010
First Submitted That Met QC Criteria
February 1, 2010
First Posted (Estimate)
February 2, 2010
Study Record Updates
Last Update Posted (Estimate)
December 21, 2011
Last Update Submitted That Met QC Criteria
December 20, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-CGR-DUM-2009/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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