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

This study has been completed.
Sponsor:
Collaborator:
Hellenic Cardiovascular Research Society
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01061086
First received: February 1, 2010
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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.


Condition
Acute Coronary Syndromes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Epidemiological Study of Acute Coronary Syndromes in The Greek Population

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • To estimate the "pain-to-door-time" throughout different regions in Greece. [ Time Frame: first visit - 1st day (cross-sectional part) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 418
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients over 18 years old admitted to the hospital with Acute Coronary Syndrome.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Emergency Room

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061086

Locations
Greece
Research Site
Athens, Attiki, Greece
Research Site
Chania, Chanion, Greece
Research Site
Heraklion, Herakliou, Greece
Research Site
Ioannina, Ioanninon, Greece
Research Site
Ptolemaida, Kozani, Greece
Research Site
Larissa, Larrisis, Greece
Research Site
Volos, Magnisias, Greece
Research Site
Eddesa, Pella, Greece
Research Site
Komotini, Rodopi, Greece
Research Site
Chalkida, Greece
Research Site
Chios, Greece
Sponsors and Collaborators
AstraZeneca
Hellenic Cardiovascular Research Society
Investigators
Study Director: Panagiotis Pontikis AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01061086     History of Changes
Other Study ID Numbers: NIS-CGR-DUM-2009/1
Study First Received: February 1, 2010
Last Updated: December 20, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
Acute Coronary Syndromes
Epidemiology
Management of disease
Outcomes
Greece

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014