Status:
COMPLETED
Long-Term Follow-Up and Management Patterns of Patients With Acute Coronary Syndrome in Middle East and Africa
Lead Sponsor:
AstraZeneca
Conditions:
Acute Coronary Syndrom
Eligibility:
All Genders
Brief Summary
A multinational, prospective and observational study that will assess the management of ACS in real-life practices in Middle East North Africa area.
Detailed Description
The aim of this Middle Eastern and African study is to describe the short- and long-term (i.e. up to 3 years following the index event) management in patients hospitalized for an Acute Coronary Syndro...
Eligibility Criteria
Inclusion
- Patients presenting to the emergency room (or equivalent) and diagnosed with UA, STEMI or NSTEMI will be eligible to participate if all the following criteria apply:
- Provision of subject informed consent.
- Contact Order Form has been provided.
- Female and/or male aged 18 years and over.
- Diagnosis of STEMI, NSTEMI or UA using the following definitions:
- Criteria for STEMI diagnosis :
- History of chest pain/discomfort, and
- Persistent ST-segment elevation (\> 30 min) of ≥ 0.1 mV in 2 or more contiguous ECG leads or presumed new left bundle branch block (LBBB) on admission, and
- Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the upper reference limit.
- Criteria for NSTEMI diagnosis :
- (a) History of chest pain/discomfort, and (d) Lack of persistent ST-segment elevation, LBBB or intraventricular conduction disturbances, and (e) Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the upper reference limit.
- Criteria for Unstable Angina diagnosis :
- Symptoms of angina at rest or on minimal exercise, and
- (Transient) ST-T changes, and
- No significant increase in biomarkers of necrosis but objective evidence of ischemia by non-invasive imaging or significant coronary stenosis (at angiography).
- Hospitalized within 24 hours of onset of symptoms during the current episode\* or transferred from another hospital within 24 hours of the onset of symptoms\*\*.
- In case of intermittent symptoms, the symptoms onset is that of the last episode \*\* If the referred hospital can get the initial data of the patient from the transferring hospital, transferring period is not considered as a limitation for patient initiation
Exclusion
- Patients will not be eligible to participate if any of the following exclusion criteria are present:
- UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal bleeding or post-PCI.
- UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
- Presence of any condition/circumstance which in the opinion of the Investigator could significantly limit the complete follow-up of the patient (i.e. tourist, nonnative speaker or does not understand the local language, psychiatric disturbances).
- Already included in TOURACO observational study by another center/investigator.
- Presence of serious/severe co-morbidities in the opinion of the Investigator which may limit short-term (i.e. 6 months) life expectancy.
- If participating in any interventional clinical trial, should be adapted to each country local regulation.
- Patients with any psychotic disorders.
- Pregnancy.
Key Trial Info
Start Date :
December 28 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2020
Estimated Enrollment :
1191 Patients enrolled
Trial Details
Trial ID
NCT03362463
Start Date
December 28 2015
End Date
April 2 2020
Last Update
April 1 2021
Active Locations (1)
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1
Research Site
Doha, Qatar