Portuguese Registry on Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— ProACS  

Official title:

Portuguese Registry on Acute Coronary Syndromes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01642329
• Other study ID #: ProACS
• Secondary ID: ProACS
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2012
• Last updated: October 7, 2016
• Start date: January 2002
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Portuguese Society of Cardiology
• Contact: Sandra M Corker, Drª
• Phone: +351 239 838 101
• Email: sandra.corker[@]spc.pt
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Observational

Clinical Trial Summary

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.

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Portugal	CNCDC	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
Portuguese Society of Cardiology

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major bleeding	In Hospital major bleeding based on GUSTO definition	In hospital major bleeding	Yes
Primary	Hospital mortality in patients admitted for acute coronary syndrome	Evaluation of hospital mortality rate of patients admitted for acute coronary syndrome	Hospital dead in patients admitted with acute coronary syndrome	Yes
Secondary	major adverse cardiac events (MACE)	MACE In-hospital major adverse cardiac event (death, myocardial infarction,heart failure,stroke,)	In-hospital MACE in patients admitted for acute coronary syndrome	Yes

External Links

•   National Center for Data Collection in Cardiology
•   Portuguese Society of Cardiology