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
  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

Further study details as provided by Portuguese Society of Cardiology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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,)


Other Outcome Measures:
  • 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)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642329

Contacts
Contact: Sandra M Corker, Drª +351 239 838 101 sandra.corker@spc.pt

Locations
Portugal
CNCDC Recruiting
Coimbra, Portugal, 3000-306
Contact: Sandra M Corker    +351 239 838 101    sandra.corker@spc.pt   
Principal Investigator: Lino Gonçalves, Prof         
Sponsors and Collaborators
Portuguese Society of Cardiology
Investigators
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
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014