Clinical trial NCT01061086: An Epidemiological Study of Acute Coronary Syndromes in The Greek Population. The TARGET Study
Official title: An Epidemiological Study of Acute Coronary Syndromes in The Greek Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndromes
Keywords: Acute Coronary Syndromes
Epidemiology
Management of disease
Outcomes
Greece
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Hellenic Cardiovascular Research Society
First posted: 2010-02-02
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency Room

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: first visit - 1st day (cross-sectional part)
measure: 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.
timeFrame: follow up visit - 6th month (prospective part)
Secondary outcomes:
measure: To estimate the proportion of patients admitted to the hospital with STEMI, NSTEMI and unstable angina.
timeFrame: first visit - 1st day (cross-sectional part)
measure: To estimate the "pain-to-door-time" throughout different regions in Greece.
timeFrame: first visit - 1st day (cross-sectional part)
measure: 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.
timeFrame: follow up visit - 6th month (prospective part)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Research Site
state: Attiki
city: Chania
country: Greece
facility: Research Site
state: Chanion
city: Heraklion
country: Greece
facility: Research Site
state: Herakliou
city: Ioannina
country: Greece
facility: Research Site
state: Ioanninon
city: Ptolemaida
country: Greece
facility: Research Site
state: Kozani
city: Larissa
country: Greece
facility: Research Site
state: Larrisis
city: Volos
country: Greece
facility: Research Site
state: Magnisias
city: Eddesa
country: Greece
facility: Research Site
state: Pella
city: Komotini
country: Greece
facility: Research Site
state: Rodopi
city: Chalkida
country: Greece
facility: Research Site
city: Chios
country: Greece
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Panagiotis Pontikis
role: STUDY_DIRECTOR
References: