Coronary Artery DiseasePHAETHONNCT02420808
An Epidemiological Cohort Study of Acute Coronary Syndromes in The Greek Population. The PHAETHON Study
An observational study of Coronary Artery Disease, run by Hellenic Cardiovascular Research Society at 1 site in Greece.
Trial summary
A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 800 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2012to Jan 2014
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ACS
Who may be able to join
- Informed Consent
- > 25 years
- Admission in hospital within 24 hours from beginning of symptoms of transfer from antother hospital within 24 hours from beginning of symptoms.
- Acute Coronary Syndrom
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece.
Read the detailed description
A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece.
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, STEMI, non STEMI, Unstable angina, Greece
- Medical subject headings
- Coronary Artery Disease, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Angina, Unstable
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of patients with Acute Coronary Syndromes.
Assessment of the epidemiological characteristics of patients who were hospitalized with a diagnosis of ACS. Evaluation of the therapeutic strategy and its outcome.
Measured: 6 months
Secondary outcomes (6)
Estimation of the percentage of patients.
Estimation of the percentage of patients who were hospitalized with STEMI, NSTEMI and unstable angina.
Measured: Baseline
Description of the methods of patients' evacuation.
Description of the methods of patients' evacuation from the scene of the incident to the receiving hospital where was processed the treatment for ACS.
Measured: Baseline
Estimation of the interval until the arrival in the hospital.
Estimation of the duration from the onset of pain until the arrival in the receiving hospital at various locations.
Measured: Baseline
Evaluation of the blood test analysis during hospitalization.
Evaluation of hematological, biochemical parameters and myocardial necrosis markers during hospitalization.
Measured: Baseline
Description of the administered medication.
Description of the pharmaceutical treatment administered during hospitalization and monitoring period.
Measured: Baseline - 6 months
Evaluation of the male patients with erectile dysfunction.
Estimation of the percentage of the male patients with erectile dysfuction based to a predesigned questionnaire and investigation of the possible association with the treatment's outcome.
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cardiovascular Research Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420808
- Sponsor's protocol ID
- PHAETHON
- Acronym
- PHAETHON
- Status last verified
- Mar 2017
- First submitted
- 15 Apr 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Cohort Study of Acute Coronary Syndromes in The Greek Population. The PHAETHON Study
- ClinicalTrials.gov ID
- NCT02420808
- Acronym / sponsor ID
- PHAETHON / PHAETHON
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, STEMI, non STEMI, Unstable angina, Greece
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Hellenic Cardiovascular Research SocietyUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 Apr 2015 (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.
A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece.
Detailed description
A nationwide registry of patients with acute coronary disease to evaluate epidemiological patient characteristics, medical management, implementation of invasive strategy, patient outcome and impact on quality of life in Greece.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ACS
Key inclusion criteria (4 listed)
- Informed Consent
- > 25 years
- Admission in hospital within 24 hours from beginning of symptoms of transfer from antother hospital within 24 hours from beginning of symptoms.
- Acute Coronary Syndrom
Key exclusion criteria (1 listed)
- -
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
Evaluation of patients with Acute Coronary Syndromes.
Time frame: 6 months
Assessment of the epidemiological characteristics of patients who were hospitalized with a diagnosis of ACS. Evaluation of the therapeutic strategy and its outcome.
6 secondary outcomes
Estimation of the percentage of patients.
Time frame: Baseline
Description of the methods of patients' evacuation.
Time frame: Baseline
Estimation of the interval until the arrival in the hospital.
Time frame: Baseline
Evaluation of the blood test analysis during hospitalization.
Time frame: Baseline
Description of the administered medication.
Time frame: Baseline - 6 months
Evaluation of the male patients with erectile dysfunction.
Time frame: Baseline - 6 months
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 3 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Hellenic Cardiovascular Research Society at 1 site 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 4 inclusion and 1 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evaluation of patients with Acute Coronary Syndromes. (time frame: 6 months). 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 3 Mar 2017.