Portuguese Registry on Acute Coronary Syndromes

NCT ID: NCT01642329

Last Updated: 2016-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this Registry is creating a database management that allows continuous monitoring characteristics, evolution, prognostic indicators and management of patients with ACS admitted in Portuguese Hospitals, and identify the appropriateness of clinical practice recommendations for diagnosis and treatment of ACS and monitor its evolution.

Detailed Description

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Cardiovascular diseases remain the principal causes of death in Portugal and approximately one quarter of these are directly to ischemic heart disease, especially Acute Coronary Syndromes (ACS).

In order to reduce mortality for ACS, a significant number of new drugs and new techniques have been introduced into clinical practice, resulting in important heterogeneity of approach and treatment of patients with ACS.

The Portuguese Society of Cardiology have sought to review and incorporate in its recommendations the evidence to date, with the aim to standardize diagnosis and treatment of patients with ACS, which is not always able to in daily practice.

Since it is essential to characterize the national reality of the ACS, the Portuguese Society of Cardiology has promoted the Portuguese registry on Acute Coronary Syndromes, aimed at bridging the knowledge gaps in this area of cardiovascular disease.

This will include all adult patients (≥ 18 years) diagnosed with Acute Coronary Syndrome (ACS) with \<48 hours of evolution. The inclusion is of responsibility of the last service of Cardiology where the patient was hospitalized. The ACS is set to the presence of angina at rest last 48 hours, with 1) ischemic electrocardiographic changes ST-segment deviations or negative T waves, and / or 2) elevation of biomarker (cardiac troponin and CK-MB) above the reference value. For diagnosis ACS with ST elevation is considered to be persistently elevated (\> 30 minutes) of the ST segment. The rest should be considered as ACS ST-segment elevation. In the absence of angina, the SCA will be considered consistent elevation (curve ascending / descending) biomarker (above reference value for cardiac troponin or higher 2 times the value of reference to the CK-MB) associated with other clinical manifestations such as ill-defined chest discomfort or dyspnea.

Are included patients participating in clinical trials

Are excluded patients with MI after revascularization procedures (EAM type 4 and 5) and MI type 2 (classification according to the redefinition of Myocardial Infarction, 2007 the Joint ESC / ACCF / AHA / WHF Task Force)

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* presence of angina at rest last 48 hours, with: 1) ischemic electrocardiographic changes - ST-segment deviations or negative T waves, and / or 2) elevation of biomarker(cardiac troponin and CK-MB) above the reference value.

Exclusion Criteria

* patients with MI after revascularization procedures (EAM type 4 and 5) and MI type 2 (classification according to the redefinition of Myocardial Infarction, 2007 the Joint ESC / ACCF / AHA / WHF Task Force).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Portuguese Society of Cardiology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge V Mimoso, MD

Role: PRINCIPAL_INVESTIGATOR

Portuguese Society of Cardiology

Locations

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CNCDC

Coimbra, Coimbra District, Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Sandra M Corker, Drª

Role: CONTACT

+351 239 838 101

Facility Contacts

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Sandra M Corker

Role: primary

+351 239 838 101

Related Links

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http://www.spc.pt/spc/

Portuguese Society of Cardiology

Other Identifiers

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ProACS

Identifier Type: REGISTRY

Identifier Source: secondary_id

ProACS

Identifier Type: -

Identifier Source: org_study_id

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