Portuguese Registry on Interventional Cardiology

Coronary Artery Disease Clinical Trial

— PRIC  

Official title:

Portuguese Registry on Interventional Cardiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01867801
• Other study ID #: RNCI
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2013
• Last updated: June 8, 2017
• Start date: January 2002
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Portuguese Society of Cardiology
• Contact: Sandra M Corker
• Phone: 00351 239 838 101
• Email: sandra.corker[@]spc.pt
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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 undergoing coronary angioplasty in Portuguese Hospitals, and identify the appropriateness of clinical and interventional practice recommendations for diagnosis and treatment of coronary disease and monitoring its evolution.

Description:

Cardiovascular disease remains the main cause of death in Portugal and approximately one quarter of these are directly to ischemic heart disease. In order to better characterize percutaneous coronary intervention in Portugal, the Portuguese Society of Cardiology has promoted the Portuguese registry on percutaneous coronary intervention.

This will include all adult patients (≥ 18 years), eligible for percutaneous coronary intervention (PCI) in accordance with PCI state-of-art recommendations (including unstable and stable coronary disease). The Cardiology department where the patient has been hospitalized is responsible for the patient inclusion in the study.

Excluded patients are those in whom the preferred treatment is Coronary Artery Bypass Graft (CABG), age under 18 years or life expectancy of less than 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Patients with:

• stable angina or,

• stabilized angina pectoris or,

• atypical chest pain or,

• no chest pain but with documented silent ischemia

2. At least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium

3. Eligible for PCI

4. Informed consent

Exclusion Criteria:

1. Patients in whom the preferred treatment is CABG;

2. Contra-indication to dual antiplatelet therapy

3. Coronary artery disease precluding PCI

4. A life expectancy of less than 1 year

5. Age under 21

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Portugal	CNCDC	Coimbra

Sponsors (2)

Lead Sponsor	Collaborator
Portuguese Society of Cardiology	Portuguese Association of Interventional Cardiology

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac event rate (MACE) MACE: A composite of all cause death, documented Myocardial Infarction (MI), unplanned hospitalization leading to urgent revascularization.		24 months
Secondary	Total mortality	Total mortality at 12 month	12 month

External Links

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