An Epidemiological Study of Acute Coronary Syndromes in The Greek Population. The TARGET Study
This study has been completed.
Sponsor:
AstraZeneca
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
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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
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 June 17, 2013