Clinical Trial on Coronary Artery Disease - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Coronary Artery Disease

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

Greece
- - Chalkida, Greece
    - General Hospital of Chalkida

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
Description of the administered medication. Time Frame: Baseline - 6 months	Description of the pharmaceutical treatment administered during hospitalization and monitoring period.	Baseline - 6 months
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.

Sponsor

Hellenic Cardiovascular Research Society

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