- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420808
An Epidemiological Cohort Study of Acute Coronary Syndromes in The Greek Population. The PHAETHON Study (PHAETHON)
March 1, 2017 updated by: Hellenic Cardiovascular Research Society
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 Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chalkida, Greece
- General Hospital of Chalkida
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with ACS
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimation of the percentage of patients.
Time Frame: Baseline
|
Estimation of the percentage of patients who were hospitalized with STEMI, NSTEMI and unstable angina.
|
Baseline
|
|
Description of the methods of patients' evacuation.
Time Frame: Baseline
|
Description of the methods of patients' evacuation from the scene of the incident to the receiving hospital where was processed the treatment for ACS.
|
Baseline
|
|
Estimation of the interval until the arrival in the hospital.
Time Frame: Baseline
|
Estimation of the duration from the onset of pain until the arrival in the receiving hospital at various locations.
|
Baseline
|
|
Evaluation of the blood test analysis during hospitalization.
Time Frame: Baseline
|
Evaluation of hematological, biochemical parameters and myocardial necrosis markers during hospitalization.
|
Baseline
|
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Description of the administered medication.
Time Frame: Baseline - 6 months
|
Description of the pharmaceutical treatment administered during hospitalization and monitoring period.
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Baseline - 6 months
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|
Evaluation of the male patients with erectile dysfunction.
Time Frame: Baseline - 6 months
|
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.
|
Baseline - 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
April 15, 2015
First Submitted That Met QC Criteria
April 17, 2015
First Posted (Estimate)
April 20, 2015
Study Record Updates
Last Update Posted (Actual)
March 3, 2017
Last Update Submitted That Met QC Criteria
March 1, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHAETHON
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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