Portuguese Registry on Acute Coronary Syndromes (ProACS)

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome

Detailed 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)

• Study Type: Observational
• Enrollment (Anticipated): 50000

Contacts and Locations

• Study Contact: Name: Sandra M Corker, Drª; Phone Number: +351 239 838 101; Email: sandra.corker@spc.pt

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-306
    • Recruiting
    • CNCDC
    • Contact: Sandra M Corker; Phone Number: +351 239 838 101; Email: sandra.corker@spc.pt
    • Principal Investigator: Lino Gonçalves, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	In Hospital major bleeding based on GUSTO definition	In hospital major bleeding

Collaborators and Investigators

• Sponsor: Portuguese Society of Cardiology
• Investigators: Principal Investigator: Jorge V Mimoso, MD, Portuguese Society of Cardiology

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: July 13, 2012
• First Submitted That Met QC Criteria: July 13, 2012
• First Posted (ESTIMATE): July 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Myocardial Infarction; Angina, Unstable
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: ProACS (REGISTRY: Portuguese Registry on Acute Coronary Syndromes)