Portuguese Registry on Interventional Cardiology

• Conditions: Coronary Artery Disease

• Registration Number: NCT01867801
• Lead Sponsor: Portuguese Society of Cardiology

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-05-29
• Study First Posted: 2013-06-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-08
• Last Update Posted: 2017-06-09
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Total mortality	12 month	Total mortality at 12 month

Trial Locations

Locations (1)

CNCDC; 🇵🇹 Coimbra, Portugal