Portuguese Registry on Acute Coronary Syndromes (ProACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Portuguese Society of Cardiology
Sponsor:
Information provided by (Responsible Party):
Portuguese Society of Cardiology
ClinicalTrials.gov Identifier:
NCT01642329
First received: July 13, 2012
Last updated: March 26, 2013
Last verified: March 2013

July 13, 2012
March 26, 2013
January 2002
December 2012   (final data collection date for primary outcome measure)
Hospital mortality in patients admitted for acute coronary syndrome [ Time Frame: Hospital dead in patients admitted with acute coronary syndrome ] [ Designated as safety issue: Yes ]
Evaluation of hospital mortality rate of patients admitted for acute coronary syndrome
Not Provided
Complete list of historical versions of study NCT01642329 on ClinicalTrials.gov Archive Site
major adverse cardiac events (MACE) [ Time Frame: In-hospital MACE in patients admitted for acute coronary syndrome ] [ Designated as safety issue: Yes ]
MACE In-hospital major adverse cardiac event (death, myocardial infarction,heart failure,stroke,)
Not Provided
Major bleeding [ Time Frame: In hospital major bleeding ] [ Designated as safety issue: Yes ]
In Hospital major bleeding based on GUSTO definition
Not Provided
 
Portuguese Registry on Acute Coronary Syndromes
Portuguese Registry on Acute Coronary Syndromes

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.

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)

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

no samples retained

Probability Sample

All adult patients with Acute Coronary Syndrome (ACS) with <48 hours of evolution, admitted to Portuguese Hospitals.

Acute Coronary Syndrome
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40000
Not Provided
December 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Sandra M Corker, Drª +351 239 838 101 sandra.corker@spc.pt
Portugal
 
NCT01642329
ProACS, ProACS
No
Portuguese Society of Cardiology
Portuguese Society of Cardiology
Not Provided
Principal Investigator: Jorge V Mimoso, MD Portuguese Society of Cardiology
Portuguese Society of Cardiology
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP