Portuguese Registry on Acute Coronary Syndromes (ProACS)
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Purpose
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.
| Condition |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Portuguese Registry on Acute Coronary Syndromes |
- 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
- 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,)
- Major bleeding [ Time Frame: In hospital major bleeding ] [ Designated as safety issue: Yes ]In Hospital major bleeding based on GUSTO definition
Biospecimen Retention: None Retained
no samples retained
| Estimated Enrollment: | 40000 |
| Study Start Date: | January 2002 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All adult patients with Acute Coronary Syndrome (ACS) with <48 hours of evolution, admitted to Portuguese Hospitals.
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).
Contacts and Locations| Contact: Sandra M Corker, Drª | +351 239 838 101 | sandra.corker@spc.pt |
| Portugal | |
| CNCDC | Recruiting |
| Coimbra, Portugal, 3000-306 | |
| Contact: Sandra M Corker +351 239 838 101 sandra.corker@spc.pt | |
| Principal Investigator: Lino Gonçalves, Prof | |
| Principal Investigator: | Jorge V Mimoso, MD | Portuguese Society of Cardiology |
More Information
Additional Information:
No publications provided
| Responsible Party: | Portuguese Society of Cardiology |
| ClinicalTrials.gov Identifier: | NCT01642329 History of Changes |
| Other Study ID Numbers: | ProACS, ProACS |
| Study First Received: | July 13, 2012 |
| Last Updated: | March 26, 2013 |
| Health Authority: | Portugal: Ethics Committee for Clinical Research |
Keywords provided by Portuguese Society of Cardiology:
|
Myocardial Infarction Angina, Unstable |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013