An Epidemiological Study of Acute Coronary Syndromes in The Greek Population. The TARGET Study

Acute Coronary Syndromes Clinical Trial

— TARGET  

Official title:

An Epidemiological Study of Acute Coronary Syndromes in The Greek Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061086
• Other study ID #: NIS-CGR-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: December 20, 2011
• Start date: January 2010
• Est. completion date: February 2011

Study information

• Verified date: December 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: February 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Syndrome

Locations

Country	Name	City	State
Greece	Research Site	Athens	Attiki
Greece	Research Site	Chalkida
Greece	Research Site	Chania	Chanion
Greece	Research Site	Chios
Greece	Research Site	Eddesa	Pella
Greece	Research Site	Heraklion	Herakliou
Greece	Research Site	Ioannina	Ioanninon
Greece	Research Site	Komotini	Rodopi
Greece	Research Site	Larissa	Larrisis
Greece	Research Site	Ptolemaida	Kozani
Greece	Research Site	Volos	Magnisias

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Hellenic Cardiovascular Research Society

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		first visit - 1st day (cross-sectional part)	No
Primary	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.		follow up visit - 6th month (prospective part)	No
Secondary	To estimate the proportion of patients admitted to the hospital with STEMI, NSTEMI and unstable angina.		first visit - 1st day (cross-sectional part)	No
Secondary	To estimate the "pain-to-door-time" throughout different regions in Greece.		first visit - 1st day (cross-sectional part)	No
Secondary	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.		follow up visit - 6th month (prospective part)	No