Acute Coronary SyndromesTARGETNCT01061086
An Epidemiological Study of Acute Coronary Syndromes in The Greek Population. The TARGET Study
An observational study of Acute Coronary Syndromes, run by AstraZeneca at 11 sites in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 418 participants
- Where
- 11 sitesGreece
- Study dates
- Jan 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency Room
Who may be able to join
- Diagnosis of an ACS (STEMI, NSTEMI, UA).
- Informed Consent
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Greece11 sites
Research Site
Athens, Attica
Research Site
Chalcis, Chalkida
Research Site
Chania, Chanion
Research Site
Chios, Chios
Research Site
Eddesa, Pella
Research Site
Heraklion, Herakliou
Research Site
Ioannina, Ioanninon
Research Site
Komotini, Rodopi
Research Site
Larissa, Larrisis
Research Site
Ptolemaida, Kozani
Research Site
Volos, Magnisias
About this study
Official title: An Epidemiological Study of Acute Coronary Syndromes in The Greek Population
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.
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Coronary Syndromes, Epidemiology, Management of disease, Outcomes, Greece
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients over 18 years old admitted to the hospital with Acute Coronary Syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: first visit - 1st day (cross-sectional part)
To estimate the "pain-to-door-time" throughout different regions in Greece.
Measured: 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.
Measured: follow up visit - 6th month (prospective part)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hellenic Cardiovascular Research Society
- Responsible party
- Sponsor
- Investigators
- Panagiotis Pontikis, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061086
- Sponsor's protocol ID
- NIS-CGR-DUM-2009/1
- Acronym
- TARGET
- Status last verified
- Dec 2011
- First submitted
- 1 Feb 2010
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Study of Acute Coronary Syndromes in The Greek Population
- ClinicalTrials.gov ID
- NCT01061086
- Acronym / sponsor ID
- TARGET / NIS-CGR-DUM-2009/1
- Conditions
- Acute Coronary Syndromes
- Keywords
- Acute Coronary Syndromes, Epidemiology, Management of disease, Outcomes, Greece
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Hellenic Cardiovascular Research Society
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients over 18 years old admitted to the hospital with Acute Coronary Syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Room
Key inclusion criteria (2 listed)
- Diagnosis of an ACS (STEMI, NSTEMI, UA).
- Informed Consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
3 secondary outcomes
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)
To estimate the "pain-to-door-time" throughout different regions in Greece.
Time frame: 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.
Time frame: follow up visit - 6th month (prospective part)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagiotis Pontikis study director
AstraZeneca
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by AstraZeneca at 11 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: first visit - 1st day (cross-sectional part)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2011.