NCT01061086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

December 21, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

February 1, 2010

Last Update Submit

December 20, 2011

Conditions

Keywords

Acute Coronary SyndromesEpidemiologyManagement of diseaseOutcomesGreece

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (3)

  • To estimate the proportion of patients admitted to the hospital with STEMI, NSTEMI and unstable angina.

    first visit - 1st day (cross-sectional part)

  • To estimate the "pain-to-door-time" throughout different regions in Greece.

    first visit - 1st day (cross-sectional part)

  • 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)

Study Arms (1)

1

Patients over 18 years old admitted to the hospital with Acute Coronary Syndrome.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Emergency Room

You may qualify if:

  • Diagnosis of an ACS (STEMI, NSTEMI, UA).
  • Informed Consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Athens, Attica, Greece

Location

Research Site

Chalcis, Chalkida, Greece

Location

Research Site

Chania, Chanion, Greece

Location

Research Site

Chios, Chios, Greece

Location

Research Site

Heraklion, Herakliou, Greece

Location

Research Site

Ioannina, Ioanninon, Greece

Location

Research Site

Ptolemaida, Kozani, Greece

Location

Research Site

Larissa, Larrisis, Greece

Location

Research Site

Volos, Magnisias, Greece

Location

Research Site

Eddesa, Pella, Greece

Location

Research Site

Komotini, Rodopi, Greece

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Panagiotis Pontikis

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 2, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

February 1, 2011

Last Updated

December 21, 2011

Record last verified: 2011-12

Locations