Portuguese Registry on Interventional Cardiology (PRIC)

June 8, 2017 updated by: Portuguese Society of Cardiology
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-306
        • Recruiting
        • CNCDC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients admitted to Portuguese hospitals for percutaneous coronary intervention

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac event rate (MACE) MACE: A composite of all cause death, documented Myocardial Infarction (MI), unplanned hospitalization leading to urgent revascularization.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total mortality
Time Frame: 12 month
Total mortality at 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portuguese Society of Cardiology

Collaborators

Portuguese Association of Interventional Cardiology

Investigators

  • Principal Investigator: Marco Costa, MD, Portuguese Society of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

May 29, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNCI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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